This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses Pharmalink's history, capabilities, experience, and case studies. Pharmalink was founded in 1998 and works with 18 of the top 20 healthcare companies. They have offices globally and can provide regulatory assistance across the entire product lifecycle from non-clinical development to post-approval tasks. Case studies demonstrate experience with large, global projects involving compliance, mergers and acquisitions, and product licenses.
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses who they are, what services they provide, their global regulatory experience, and two case studies. Key details include that Pharmalink has 155 staff, works with 18 of the top 20 healthcare companies, provides regulatory solutions across the product lifecycle, has offices and affiliates worldwide, and has experience helping clients with projects of all sizes involving domestic, international, and multinational regulatory requirements. Their case studies describe large-scale compliance and biosimilar product review projects for pharmaceutical clients.
AxSource is a healthcare and information technology solutions provider specializing in consulting services for various industries including pharmaceutical, biologics, medical devices, and food. They provide regulatory, quality, engineering and IT consulting services to help clients with activities like new product launches and emerging market operations. AxSource consists of highly qualified consultants with decades of experience in North America, Europe, Mexico, and Asia.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
Activities of India's leading Software Validation company. We mainly focus on International job , GAP Analyses, 483 - warning letter replies and Remedies, Training to Staff on Data Integrity, 21 CFR Part 11 Compliance, Computer Systems Validation, Annex 11, GAMP5 and make them walk the talk. Say what you Do and Do what you Say
Manoj Kumar Verma has over 13 years of experience in quality assurance roles in the biotech and pharmaceutical industries. He has experience leading quality assurance teams and qualifying facilities and products for regulatory inspections. Currently, he works for Hyde E & C India Pvt. Ltd. as an Assistant Manager of Validation, where he plans and executes commissioning and qualification projects in pharmaceutical plants in India and overseas. He has a MBA in Total Quality Management and an M.Sc. in Microbiology.
This document provides an overview of Pharmalink, a regulatory affairs consulting firm. It discusses who they are, what services they provide, their global regulatory experience, and two case studies. Key details include that Pharmalink has 155 staff, works with 18 of the top 20 healthcare companies, provides regulatory solutions across the product lifecycle, has offices and affiliates worldwide, and has experience helping clients with projects of all sizes involving domestic, international, and multinational regulatory requirements. Their case studies describe large-scale compliance and biosimilar product review projects for pharmaceutical clients.
AxSource is a healthcare and information technology solutions provider specializing in consulting services for various industries including pharmaceutical, biologics, medical devices, and food. They provide regulatory, quality, engineering and IT consulting services to help clients with activities like new product launches and emerging market operations. AxSource consists of highly qualified consultants with decades of experience in North America, Europe, Mexico, and Asia.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
This document discusses Targovax's strategy for outsourcing clinical manufacturing and quality control activities. As a virtual biotech company, Targovax outsources all development, manufacturing, and testing of its three investigational medicinal products - a peptide vaccine (TG), recombinant GM-CSF, and an oncolytic virus (ONCOS-102). The document describes Targovax's current contract manufacturing organizations for clinical supply and its plans to select new partners to support late-stage clinical trials and commercialization. A multi-stage selection process is outlined involving screening of potential partners, requests for proposals, audits, and selection of organizations meeting Targovax's regulatory and capacity requirements.
Activities of India's leading Software Validation company. We mainly focus on International job , GAP Analyses, 483 - warning letter replies and Remedies, Training to Staff on Data Integrity, 21 CFR Part 11 Compliance, Computer Systems Validation, Annex 11, GAMP5 and make them walk the talk. Say what you Do and Do what you Say
Manoj Kumar Verma has over 13 years of experience in quality assurance roles in the biotech and pharmaceutical industries. He has experience leading quality assurance teams and qualifying facilities and products for regulatory inspections. Currently, he works for Hyde E & C India Pvt. Ltd. as an Assistant Manager of Validation, where he plans and executes commissioning and qualification projects in pharmaceutical plants in India and overseas. He has a MBA in Total Quality Management and an M.Sc. in Microbiology.
KVS Technologies provides quality validation services to help pharmaceutical and medical device companies increase profitability and comply with regulations. They have over 25 years of experience in the pharmaceutical field and work with clients around the world. Their services include computer system validation, laboratory equipment validation, and clinical research software validation to help clients get regulatory approval and ensure quality production.
Life Scientific Ltd is a contract research organization that has assisted biopharmaceutical, pharmaceutical, and agri-business clients since 1995. It provides services such as method development, validation, analysis, and regulatory support. Its biopharmaceutical division specializes in developing and validating immunoassay and cell-based methods for analyzing biopharmaceuticals, biomarkers, and related factors. It has GLP and GMP certified facilities in Dublin.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
This document provides an agenda for the "IVD Regulatory and Strategic Forum" conference taking place on December 8-9, 2015 in Dublin, Ireland. The conference will feature keynote speakers and panels discussing topics related to in vitro diagnostic (IVD) medical device regulations, including updates on the EU's new IVD Regulation and how companies can prepare for its implementation. Specific sessions will cover issues like the role of notified bodies, clinical evidence requirements, post-market surveillance, software/mobile medical apps, and navigating regulations in different global markets. Pre-conference workshops on December 7 will address UDI implementation experiences and a pilot program for revised adverse event reporting forms.
The document provides an overview of SNC-Lavalin Pharma's expertise in the biopharmaceutical industry. It discusses their services, technical expertise, knowledge of applicable standards and regulations, systems life cycle approach, and knowledge of special systems and elements relevant to the industry such as layout planning, process and automation, water systems, environment systems, dust control, effluent treatment, room finishes, and safety issues. SNC-Lavalin Pharma has over 20 years of experience providing engineering services for biotech and pharmaceutical clients.
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
The document provides an overview of City X Ray & Scan Clinic, a medical diagnostics center. Its vision is to deliver excellent patient care and benchmark quality diagnostics using ethical practices and continuous upgrades. The mission is to provide world-class and affordable diagnostic facilities to all while maintaining high standards. The clinic offers a wide range of diagnostic tests and services across radiology, pathology, cardiology, and other specialties using state-of-the-art equipment. It is committed to quality, timely reporting, and a good patient and doctor experience through well-trained staff and efficient systems. The clinic has received several accreditations and aims to set new benchmarks in healthcare delivery through continuous improvements.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Piramal Clinical Trial Services provides clinical trial manufacturing capabilities including packaging, storage, distribution, and reconciliation of investigational drugs. They offer primary and secondary packaging, kit preparation and compilation, temperature controlled storage and distribution, returns management, and support services globally. Piramal aims to offer superior customer service and uses a digital platform called TrakPack to track manufacturing, distribution, returns, and provide reporting to customers.
Biodextris specializes in providing analytical development, process development, and quality control testing services for vaccines and biologics in clinical development. Comprised of experienced scientists located in Laval, Quebec, the group has worked together since 2002 developing numerous vaccine and biologic products. They offer a range of analytical, biophysical, physiochemical, immunological, and microbial characterization assays to support product development. Biodextris also provides process development, formulation, biomanufacturing, technology transfer, project management, and regulatory consulting services.
This document provides a summary of a report on Patrys Limited's product pipeline as of 2012. The report examines Patrys' research and development focus across various therapeutic areas and provides details on pipeline products at different stages of development. It also discusses recent deals, partnerships, and financial information relating to Patrys' pipeline assets.
CoreRx is a dosage form development company specializing in preformulation, formulation development, analytical development, clinical manufacturing, and commercial manufacturing. It has experienced professionals and state-of-the-art facilities. CoreRx focuses on client satisfaction through effective communication, flexibility, speed, and high quality systems. It offers a range of services from preformulation to stability studies to meet clients' drug development needs.
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
City X Ray & Scan Clinic aims to provide world-class and affordable diagnostic facilities to all sections of society while maintaining high ethical standards. Their vision is to use a multidisciplinary approach and focus on excellence in patient care, continuous service upgrades, accurate reporting, and benchmark quality diagnostics. Their mission is to establish this clinic to provide state-of-the-art diagnostic facilities at an affordable cost while training staff to high professional standards. They have various accreditations and certifications and aim for continuous quality improvement, accuracy, and developing trust with customers through competent staff and efficient management.
This digital marketing strategy document outlines several key tactics including user participation, a viral video campaign to generate likes and shares on social media, and adapting to new trends given that strategies that were once effective may no longer be in a constantly evolving industry.
The document analyzes and compares the contents pages of three music magazines: NME, VIBE, and KERRANG. It discusses the use of imagery, logos, fonts, colors, subheadings, and taster articles across the magazines. The goal of these design elements is to attract and engage readers, reinforce the magazines' target audiences and music genres, and encourage readers to purchase the magazines.
Enviu Night BCN - Innovation In Funding Sustainable Initiatives The Role Of ...Jan-Willem Bode
This document discusses the role of crowdfunding in funding sustainable initiatives. It provides background on crowdfunding, stating that large sums are raised but mainly through donations. It then discusses benefits of crowdfunding like third party validation, network building, and market testing. Examples of crowdfunded projects are given. The document addresses how crowdfunding helps address the 'valley of death' between ideation and startup funding. Professionalization of crowdfunding is discussed to improve processes, regulation, and integrating it with other financial structures.
Pharmalink Affiliate Network provides regulatory affairs expertise around the world. They have a network of leading local consultants covering every market who can help clients with regulatory intelligence gathering, product registration, and post-marketing activities. Their consultants understand local cultures and ensure client requirements are met in a time and cost-effective manner. Pharmalink has affiliates across Europe, Africa, Eastern Europe, Asia Pacific, North America, Latin America, and the Middle East/North Africa that provide regulatory assistance wherever clients need it.
KVS Technologies provides quality validation services to help pharmaceutical and medical device companies increase profitability and comply with regulations. They have over 25 years of experience in the pharmaceutical field and work with clients around the world. Their services include computer system validation, laboratory equipment validation, and clinical research software validation to help clients get regulatory approval and ensure quality production.
Life Scientific Ltd is a contract research organization that has assisted biopharmaceutical, pharmaceutical, and agri-business clients since 1995. It provides services such as method development, validation, analysis, and regulatory support. Its biopharmaceutical division specializes in developing and validating immunoassay and cell-based methods for analyzing biopharmaceuticals, biomarkers, and related factors. It has GLP and GMP certified facilities in Dublin.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
This document provides an agenda for the "IVD Regulatory and Strategic Forum" conference taking place on December 8-9, 2015 in Dublin, Ireland. The conference will feature keynote speakers and panels discussing topics related to in vitro diagnostic (IVD) medical device regulations, including updates on the EU's new IVD Regulation and how companies can prepare for its implementation. Specific sessions will cover issues like the role of notified bodies, clinical evidence requirements, post-market surveillance, software/mobile medical apps, and navigating regulations in different global markets. Pre-conference workshops on December 7 will address UDI implementation experiences and a pilot program for revised adverse event reporting forms.
The document provides an overview of SNC-Lavalin Pharma's expertise in the biopharmaceutical industry. It discusses their services, technical expertise, knowledge of applicable standards and regulations, systems life cycle approach, and knowledge of special systems and elements relevant to the industry such as layout planning, process and automation, water systems, environment systems, dust control, effluent treatment, room finishes, and safety issues. SNC-Lavalin Pharma has over 20 years of experience providing engineering services for biotech and pharmaceutical clients.
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
The document provides an overview of City X Ray & Scan Clinic, a medical diagnostics center. Its vision is to deliver excellent patient care and benchmark quality diagnostics using ethical practices and continuous upgrades. The mission is to provide world-class and affordable diagnostic facilities to all while maintaining high standards. The clinic offers a wide range of diagnostic tests and services across radiology, pathology, cardiology, and other specialties using state-of-the-art equipment. It is committed to quality, timely reporting, and a good patient and doctor experience through well-trained staff and efficient systems. The clinic has received several accreditations and aims to set new benchmarks in healthcare delivery through continuous improvements.
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Piramal Clinical Trial Services provides clinical trial manufacturing capabilities including packaging, storage, distribution, and reconciliation of investigational drugs. They offer primary and secondary packaging, kit preparation and compilation, temperature controlled storage and distribution, returns management, and support services globally. Piramal aims to offer superior customer service and uses a digital platform called TrakPack to track manufacturing, distribution, returns, and provide reporting to customers.
Biodextris specializes in providing analytical development, process development, and quality control testing services for vaccines and biologics in clinical development. Comprised of experienced scientists located in Laval, Quebec, the group has worked together since 2002 developing numerous vaccine and biologic products. They offer a range of analytical, biophysical, physiochemical, immunological, and microbial characterization assays to support product development. Biodextris also provides process development, formulation, biomanufacturing, technology transfer, project management, and regulatory consulting services.
This document provides a summary of a report on Patrys Limited's product pipeline as of 2012. The report examines Patrys' research and development focus across various therapeutic areas and provides details on pipeline products at different stages of development. It also discusses recent deals, partnerships, and financial information relating to Patrys' pipeline assets.
CoreRx is a dosage form development company specializing in preformulation, formulation development, analytical development, clinical manufacturing, and commercial manufacturing. It has experienced professionals and state-of-the-art facilities. CoreRx focuses on client satisfaction through effective communication, flexibility, speed, and high quality systems. It offers a range of services from preformulation to stability studies to meet clients' drug development needs.
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Treated articles refers to items treated with pesticide or preservative. Learn about the regulatory requirements for selling treated articles in Canada.
City X Ray & Scan Clinic aims to provide world-class and affordable diagnostic facilities to all sections of society while maintaining high ethical standards. Their vision is to use a multidisciplinary approach and focus on excellence in patient care, continuous service upgrades, accurate reporting, and benchmark quality diagnostics. Their mission is to establish this clinic to provide state-of-the-art diagnostic facilities at an affordable cost while training staff to high professional standards. They have various accreditations and certifications and aim for continuous quality improvement, accuracy, and developing trust with customers through competent staff and efficient management.
This digital marketing strategy document outlines several key tactics including user participation, a viral video campaign to generate likes and shares on social media, and adapting to new trends given that strategies that were once effective may no longer be in a constantly evolving industry.
The document analyzes and compares the contents pages of three music magazines: NME, VIBE, and KERRANG. It discusses the use of imagery, logos, fonts, colors, subheadings, and taster articles across the magazines. The goal of these design elements is to attract and engage readers, reinforce the magazines' target audiences and music genres, and encourage readers to purchase the magazines.
Enviu Night BCN - Innovation In Funding Sustainable Initiatives The Role Of ...Jan-Willem Bode
This document discusses the role of crowdfunding in funding sustainable initiatives. It provides background on crowdfunding, stating that large sums are raised but mainly through donations. It then discusses benefits of crowdfunding like third party validation, network building, and market testing. Examples of crowdfunded projects are given. The document addresses how crowdfunding helps address the 'valley of death' between ideation and startup funding. Professionalization of crowdfunding is discussed to improve processes, regulation, and integrating it with other financial structures.
Pharmalink Affiliate Network provides regulatory affairs expertise around the world. They have a network of leading local consultants covering every market who can help clients with regulatory intelligence gathering, product registration, and post-marketing activities. Their consultants understand local cultures and ensure client requirements are met in a time and cost-effective manner. Pharmalink has affiliates across Europe, Africa, Eastern Europe, Asia Pacific, North America, Latin America, and the Middle East/North Africa that provide regulatory assistance wherever clients need it.
This document provides instructions for homeroom teachers to add comments to student report cards in Phidias Menu. Teachers should (1) select the "Teaching/Group Direction" option, then (2) select "Academics", then (3) add comments for each student by clicking the "No observations" link and typing their comment in the space provided, which has a 400 character maximum. Any questions can be directed to ivan.mercado@cojowa.edu.co.
Digital Media Day 2016_Viktoriya Tigipko (TA Ventures, Odessa International F...IDCEE
Intro presentation at Digital Media Day 2016 at the 7th Odessa International Film Festival about the current state of digital media in the world by Viktoriya Tigipko, founding Partner of a VC fund TA Ventures, President of Odessa International Film Festival, and initiator of Code Club in Ukraine.
https://www.linkedin.com/in/viktoriyatigipko
oiff.com.ua/en/index.htm
https://www.facebook.com/odessaiff/
https://www.facebook.com/TAVentures2010/
Weerada Sucharitkul (Co-founder of FilmDoo) at Digital Media Day 2016IDCEE
Weerada Sucharitkul, Co-founder of FilmDoo speaks about film distribution and what FilmDoo has to offer to filmmakers across the globe at Digital Media Day 2016 within the framework of the 7th Odessa International Film Festival.
https://www.linkedin.com/in/sucharitkul
https://www.filmdoo.com/about-us/
https://oiff.com.ua/en/index.htm
https://www.facebook.com/odessaiff/
https://www.facebook.com/TAVentures2010/
El documento resume las principales etapas de la Segunda República Española desde su proclamación en 1931 hasta el golpe de Estado de 1936 que dio inicio a la Guerra Civil. Tras la abdicación de Alfonso XIII se formó un gobierno provisional que elaboró una nueva constitución en 1931. El gobierno republicano-socialista de Azaña impulsó reformas sociales y administrativas que generaron oposición de la Iglesia y el ejército, lo que llevó a un periodo conservador entre 1933-1936 y tensiones crescientes que de
Quality assurance in the pharmaceutical industryfatboysec
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
ChemPharm is a consulting firm that provides expert services to support the pharmaceutical, biotechnology, medical device, traditional Chinese medicine, and cosmetic industries. It helps clients achieve compliance with international standards through services such as quality management system development and upgrades, validation, regulatory affairs support, and training. ChemPharm works with a variety of clients from multinational corporations to national companies and start-ups. Its goal is to be a trusted partner through high integrity, professionalism, and sharing of strategic information and vision.
Artixio MedTech Training Brochure 2023.pdfY. Yogi Raj
The document provides information about Artixio Consulting Pvt Ltd, a company that offers regulatory affairs and quality consulting, training, and services for medical devices and in vitro diagnostics. It summarizes Artixio's training programs on medical device regulations, which cover the entire product lifecycle from concept to market. The training is customized and delivered through in-person, live online, and self-paced formats. Key topics include regulations for the US, EU, Asia Pacific, and Latin America. The goal is to help clients succeed in compliance and their careers through increased knowledge and engagement.
ChemPharm is a consulting firm that provides services to the pharmaceutical, biotechnology, medical device, and cosmetics industries to help them achieve compliance with international quality standards. It has experts in areas like quality assurance, quality control, production, logistics, product development, and regulatory affairs. ChemPharm conducts activities like gap assessments, quality system implementations, audits, inspections preparations, and training. It aims to be a long-term partner to clients and help them go beyond just meeting requirements to gaining a competitive advantage.
Raaj Global Pharma Regulatory Affairs Consultants Thane-mumbai profile-updat...Rajashri Survase Ojha
Raaj-GPRAC is a Thane-Mumbai (India) based agency.
Our offerings includes but not limited to making Regulatory filing strategy, Preparation of pharmaceutical product registration dossier, filing assistance, response to regulatory queries, life cycle management, regulatory compliance audit and Training.
We offer flexible and need based services to meet customer/client requirements so as to save time and cost.
Quality Auditor and trainerProfile-G.sundarG Sundar
The document provides a curriculum vitae for G.Sundar outlining his 22 years of experience in quality assurance and regulatory compliance roles. It details his expertise in areas such as GMP, GLP, ISO standards, equipment and process validation, auditing, and preparing for regulatory inspections. It also lists recent regulatory audits he has faced, including multiple successful USFDA inspections, and audits he has conducted of API and formulation manufacturing sites.
Bilcare_GCS Quality and Regulatory OveriewBilcare GCS
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
This document provides an overview of BizBites, a business intelligence and technology solutions provider based in the UK and India since 2004 and 2011 respectively. It also describes tQmlab, one of BizBites' premier management systems for GxP operations and enabling regulatory submissions. tQmlab delivers improved productivity for QA/QC labs through customized workflows for quality control, stability testing, product release testing, and post-release quality testing. It also enables process analytical technology controls in pharmaceutical manufacturing and analytical processes.
Sai pharma solutions inc scientific-regulatory affairs-qms and c gmp consult...JRamniwas
This document provides an overview of consulting services offered by Sai Pharma Solutions Inc. related to quality management, regulatory affairs, and GMP compliance for pharmaceutical industries. The company's vision is to help clients achieve global regulatory compliance through education, training, auditing, and documentation services. Key services include GAP analyses, audits and checklists, SOP development, regulatory submissions, technical support, and online consultations. The goal is to help clients obtain regulatory approval by ensuring their facilities, equipment, methods, and personnel meet all necessary qualifications and standards.
The document provides an overview of the Avoca Quality Consortium, which was formed to develop best practices for proactive quality management of outsourced clinical trials. It discusses the state of the clinical trials industry that led to the Consortium's formation, including increased outsourcing and globalization. It then outlines the Consortium's approach, deliverables produced to date like Quality Agreements and metrics, and areas of ongoing focus such as guidelines for effective quality oversight and operationalizing proactive quality management. The overall goal is to improve quality and efficiency in clinical trials through collaboration and standardization.
This document discusses concepts of quality assurance in the pharmaceutical industry. It begins with definitions of quality assurance from WHO and ISO. It then discusses the concept of quality assurance, covering all aspects that influence drug quality. Advantages include ensuring high quality drugs while disadvantages include perfection being difficult. Quality assurance tools discussed include total quality management, quality control systems, documentation, validation, and Six Sigma methodology. Total quality management aims to continuously improve quality through participation at all levels. Quality control systems involve qualified staff and standardized procedures. Documentation and validation are important for defining systems and ensuring quality. Six Sigma uses a data-driven approach to reduce defects and improve processes.
International Regulatory Overview 2009 Rev LinkedlnMdbio
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA MetricStream Inc
This document describes a leading clinical research organization that wanted to enhance its compliance and quality management. It was manually conducting audit and corrective action processes using spreadsheets, which led to inefficiencies. It implemented the MetricStream solution to automate audit management and corrective action planning. This streamlined processes, provided better visibility and reporting, and helped ensure compliance with various regulations. The automated solution reduced cycle times and audit costs while improving precision and productivity.
This document provides an overview of quality assurance tools and techniques used in the pharmaceutical industry. It defines quality assurance and discusses its advantages in providing high quality drugs and preventing defects. Disadvantages include perfection being difficult and limits being set. Tools covered include total quality management, quality control systems, documentation, and validation. Six sigma methodology is also described as a quality assurance technique. The roles and approaches of six sigma are explained. In conclusion, quality assurance is presented as an important preventative activity for quality improvement through management and employee development.
- Indian pharmaceutical companies have increased R&D spending and are targeting international companies for contract research and manufacturing deals.
- The global pharmaceutical outsourcing market was worth $57.2 billion in 2007 and is expected to grow to $76 billion by 2010, with contract research and manufacturing services making up $55.48 billion in 2007.
- The Indian pharmaceutical outsourcing market was valued at $1.27 billion in 2007 and is projected to reach $3.33 billion by 2010, growing at a CAGR of 37.6%.
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Pharmalink Consulting is a global regulatory consulting firm founded in 1998 with offices worldwide. They provide regulatory services to pharmaceutical, biotech, medical device and other healthcare companies. Their services include regulatory strategy, submissions preparation, and interim staffing support. They have experience with projects of all sizes, from small to large multi-country undertakings. Case studies demonstrate their work on compliance projects, biosimilar submissions, multinational clinical trials, and license applications to multiple markets.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
4. Who we are
Founded in UK in 1998
Privately held
Leading independent Regulatory Affairs
Specialist
Offices in Europe, US, India and Asia-Pacific
155 Staff as of May 2011
Large, proprietary network of freelance RA
professionals worldwide
Revenues in excess of $25 million in 2010
5. Who we work with
18 of top 20 healthcare companies
Large pharmaceutical multinationals
Consumer Health organizations and divisions
Biotechnology & new technology
Clinical research organizations
Medical device companies
Generic companies
Start-up ventures
Virtual companies
6. Consumer Profile
Pharma
Biotech
Medical device
Consumer Health
Veterinary
Generics
Nutraceuticals/Other
8. What we can help with
Projects of any scale or duration
Domestic, international and multinational
projects
Interim regulatory staffing needs
Assistance at all stages of regulatory lifecycle
9. What we can help with
Non-clinical
Clinical Development
Pre-Submission Activity
Filing / Submission
Approval
Product Launch
Post-Approval
10. RA Solutions that fit your business
REGULATORY Regulatory Strategy Clinical Advertising &
Promotion/Labeling
SERVICES Regulatory agency Preparation of
meetings CTD Module 2 & 5 USPI/PLR/SPC/CDS
Filing strategy Review of protocols & User testing
Response to agency CSRs Packaging
queries CTA preparation
Advisory Committee Review of IBs
preparation Regulatory Operations
CMC & Manufacturing IRB/EC documentation
Scientific Advice
Compliance Orphan indication CTD/eCTD/dossier
Lifecycle management preparation
Pediatric development
Gap analysis & remediation Input from Subject Matter plans Submission advice
Experts
Preparation of Amendments Translation service
CTD Module 2 & 3 Medical writing
Filing Expertise
DMF preparation GCP audit Non-clinical
Validation IND/IMPD
TPM site identification Original NDA/MAA Postmarketing Maintenance Preparation of
Contract QP ANDA CTD Module 2 & 4
Import documentation and sNDA/variations Review of toxicology &
BLA pharmacology studies
licensing Annual Reporting
510K/PMA
GLP/GMP audit Postmarketing Commitments
Pre-approval inspections Safety reporting eg PSUR
11. RA Solutions that fit your business
A Regulatory Affairs team for
all your regulatory needs
Junior consultants to Subject Matter Experts
Generalists to specialists
Assistance with projects of any scale and
length
On-site or remote working on Domestic,
International, and Multinational assignments
12. How we work
Project are served by appropriate experience
– 30+ yrs to 1 yr depending on requirements
– Mainstream or specialized experienced
– Industry and/or Agency expertise
Senior Regulatory Managers assisted by
junior level staff for data intensive work
14. Global experience
Our consultants have experience in the
following regions:
Europe (EU, Switzerland, Norway, Iceland)
Middle East and Africa
North America and Canada
Central America and Caribbean Community
Latin America
Central & Eastern European states
Australia & New Zealand
Asia-Pacific
15. Global Pharmalink Offices
Cambridge, MA
Short Hills, NJ
King of Prussia, PA Maidenhead, UK
Singapore
San Francisco, CA
Mumbai, India
Hartford, CT
Washington, DC
New York, NY
Durham, NC
17. Pharmalink Affiliate Network
Access to local Regulatory Affairs
expertise when and where you need it.
The best Regulatory Affairs professionals in every
continent.
Covering every market from Argentina to Zambia.
Leading local consultants who:
– understand the culture
– will ensure your requirements are met
– save you time and money.
18. Pharmalink Affiliate Network
EUROPE
AUSTRIA | BELGIUM | CYPRUS | CZECH REPUBLIC | DENMARK | FINLAND
FRANCE | GERMANY | GREECE | IRELAND | ITALY | NETHERLANDS
PORTUGAL | SPAIN | SWEDEN | SWITZERLAND | TURKEY | UK (GLOBAL HQ)
19. Pharmalink Affiliate Network
ME-NA
ALGERIA | BAHRAIN | EGYPT | ISRAEL | JORDAN | KUWAIT | LEBANON
MOROCCO | OMAN | QATAR | SAUDI ARABIA | TUNISIA | UAE
20. Pharmalink Affiliate Network
AFRICA
ANGOLA | BOTSWANA | DEMOCRATIC REPUBLIC OF CONGO | LESOTHO
MADAGASCAR | MALAWI | MAURITIUS | MOZAMBIQUE
NAMIBIA | SOUTH AFRICA | SWAZILAND | TANZANIA | ZAMBIA | ZIMBABWE
21. Pharmalink Affiliate Network
EASTERN
EUROPE
ALBANIA | AZERBAIJAN | BOSNIA & HERZEGOVINA | BULGARIA | CROATIA
ESTONIA | GEORGIA | HUNGARY | KAZAKHSTAN
KOSOVO | MACEDONIA | MOLDOVA | MONTENEGRO | POLAND | ROMANIA
RUSSIA | SERBIA | SLOVAKIA | SLOVENIA | UKRAINE | UZBEKISTAN
22. Pharmalink Affiliate Network
ASIA PAC
AUSTRALIA | CHINA | HONG KONG | INDIA
JAPAN | MALAYSIA | NEW ZEALAND | PHILIPPINES | SINGAPORE
SOUTH KOREA | THAILAND
24. Pharmalink Affiliate Network
ARGENTINA | ARUBA | BELIZE | BRAZIL | CHILE | COLOMBIA | COSTA RICA
DOMINICAN REPUBLIC | ECUADOR | EL SALVADOR | GUATEMALA
HONDURAS | JAMAICA | MEXICO | NICARAGUA
PANAMA | PARAGUAY | PERU | PUERTO RICO | TRINIDAD | VENEZUELA
LATIN
AMERICA
26. Case Study 1
Major regulatory compliance project
CLIENT A major pharmaceutical company based in Europe.
PROJECT A large compliance project.
OBJECTIVE Review all European-registered licenses and bring into
compliance with current manufacturing site practices.
SOLUTION Pharmalink provided a dedicated team of regulatory affairs
specialists to work on the project for 3 years.
One of the key advantages that Pharmalink was able to bring to the project
was the ability to adjust the number of consultants working on the project to
fit the client’s needs and hit every deadline whilst always maintaining the
level of quality.
27. Case Study 1
Project Details
Consultants reviewed registered details against manufacturing site
documents, highlighting compliance issues.
Consultants worked with site QA departments in preparing remediation
plans for each license.
Over 600 licenses were reviewed and each phase of the project was
delivered to the client’s timelines.
Pharmalink’s staff exceeded the client’s expectations on each phase of
the defined project, resulting in the client engaging Pharmalink to
prepare all of the Variations and submit to all EU agencies in order to
bring the product licenses into compliance.
28. Case Study 2
Global Product Compliance Project
CLIENT Top 10 Pharma Company.
PROJECT Since 2004, Pharmalink Consulting have been successfully
performing a large-scale Global Quality Compliance program for a
company, covering approximately 1400 Quality Dossiers
worldwide.
OBJECTIVE
Short term – get product moving around Europe again.
Long term – bring all dossiers and licenses up to date providing
sustainable compliance.
SOLUTION
The team that Pharmalink Consulting assembled has successfully
driven all key stages of the compliance process including:
– Quality Dossier collection and collation into
CTD format
– CMC Compliance Assessment
– Product Remediation
29. Case Study 2
Project Details
Dossiers Collected – 270
Dossiers Collated – 270
Compliance Assessments Performed - 270 (10% TPM)
Remediation Packages Prepared – 564
Markets -
AT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU,
IE, IS, IT, LT, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK
30. Case Study 2
Project Details
Throughout the compliance project in Europe, the Company was forced
to halt product shipment until gap analysis was completed. This put
enormous pressure on the team, yet the impact on product shipments
remained minimal.
Various stages of the compliance process were performed remotely from
the client, across the Pharmalink offices in North America, Europe and
Asia. All objectives and milestones were successfully achieved ahead of
target dates.
The Pharmalink team reached 45 in number at the height of the activity
but remained flexible dependent on the workload so were able to adjust
accordingly. Pharmalink was able to offer office facilities for the purposes
of the project.
The resulting completion of the European section of the project meant a
satisfied client who has continued to employ Pharmalink for regulatory
activities across multiple sites in Europe and the United States.
31. Case Study 3
Organization Acquisition Project
CLIENT Top 10 Pharma Company.
PROJECT Since 2004, Pharmalink have been involved with a large scale
global integration project.
OBJECTIVE Short term – Assemble and assess documentation.
Long term – complete ownership changes and related regulatory
activity to bring dossiers and licenses in line with parent company.
The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of
the compliance process including:
- data gathering - reviewed existing documentation, job descriptions,
SOPs, job aids, interviewed staff
- Mapped process(es) - deployment,
interactions, comparison against best practice
- Recommendations presented to sponsor –
Appropriate to the organization concerned
32. Case Study 3
Project Details
Project sponsorship – It was important to get high level buy-in and support and
confirm mutual understanding of deliverables and objectives. At an early stage
effective communication and ‘marketing’ of activities was developed to overcome
potential issues.
Environmental issues – Given the cultural differences between sites, areas of
organisation Pharmalink worked with the project sponsor to identify the potential
roadblocks to a successful outcome – Often M&A ‘fallout’ can present barriers to
success.
The Pharmalink team adjusted the resources at various stages to deal with short
term increases in workload, but remained flexible. Pharmalink was able to offer
office facilities for the purposes of the project.
The resulting completion of the integration meant that the organization was able to
operate a ‘business as usual’ model, despite the uncertainty and disruption
associated with many mergers and acquisitions. A satisfied client who has
continued to employ Pharmalink for regulatory activities across multiple sites in
Europe and the United States.
33. Case Study 4
Merger & Quality Compliance Project
Large Pharmaceutical Company
CLIENT Top 10 Pharma Company.
PROJECT Since 2000, Pharmalink Consulting have been engaged in an
operational role in a license integration, site rationalization, and a
quality compliance project.
OBJECTIVE Short term – Assist client company meeting legal and commercial
obligations and targets as a result of merger.
Long term – complete source transfers and related regulatory activity
to enable seamless supply chain.
SOLUTION The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of the
compliance process including:
– site transfers including internal and TPM sites,
covering markets worldwide.
– Performed quality & compliance reviews.
34. Case Study 4
Project Details
Pharmalink was the operational regulatory partner in the UK and US for site
rationalisation and product quality compliance resulting from a high profile
merger between two large pharmaceutical companies. The key performance
indicator was the need for cost saving and manufacturing rationalisation –
central to these activities.
Pharmalink was tasked with identifying requirements, timing, and delivering site
transfers for worldwide markets. In parallel with this activity the team completed
a quality compliance review on all products that enabled a full regulatory strategy
to be available when sourcing decisions had to be made.
The Pharmalink core team of 25 was adjusted as requirements varied and
reached 60 at its peak. Following the merger activity in 2005 Pharmalink has
maintained smaller team to continue routine source transfers.
The volume and complexity of the project was managed successfully and key
merger targets achieved. The client was satisfied and continues to employ
Pharmalink for a variety of regulatory activities across its sites.
38. What else can we offer you?
1. We have demonstrable capability and
experience with large scale multi-product,
multi-national regulatory projects on
behalf of Top-20 healthcare companies.
Our familiarity with such sizeable projects
provides our clients with assurance that
the desired results can be achieved for any
project of any size.
39. What else can we offer you?
2. Our global regulatory teams are comprised
of consultants with a wide range of skills
and levels of experience.
This allows us to be able to meet client
requirements while ensuring that costs are
kept to a minimum by using the right level
of consultant for the various tasks.
40. What else can we offer you?
3. The infrastructure, both in terms of systems
and people, that we have established and in
which we have invested, underpins our
ability to undertake projects of varying scale.
We have a purpose-built, centrally-managed
IT network for all of our offices worldwide.
This will ensure peace of mind as we are
able to segregate and secure individual
company data while allowing for flexible
access.
41. What else can we offer you?
4. Whilst Pharmalink Consulting is now a
multi-national consultancy that is
recognized as a global leader in Regulatory
Affairs, we remain nimble and flexible to
react to our clients’ often urgent
requirements.
42. Thank you
UK: + 44 1628 860300
MAIDENHEAD, BERKSHIRE
USA: + 1 800 434 5808
SHORT HILLS, NJ | CAMBRIDGE, MA | HARTFORD, CT | MANHATTAN, NY | KING OF PRUSSIA, PA
DURHAM, NC | SAN FRANCISCO, CA | WASHINGTON, DC
INDIA: + 91 22 4030 9595
MUMBAI
SINGAPORE: + 65 6408 0515