Biotechnology consulting refers to the practice of organization involved in Pacificlinkconsulting services contact: San Diego, CA 92127 Phone: 858-335-1300
Speid & Associates provides consultancy services to help speed new drugs to market. They have a team of expert consultants with experience in regulatory affairs, clinical development, drug development, and other areas. Their services include strategic planning, preparing regulatory submissions, conducting due diligence, assisting with clinical trials, and training company staff. They work with clients around the world to help achieve successful global drug registration.
The document provides an overview of regulatory affairs as a career. It discusses why regulatory is an important and impactful field, the types of work involved including advising companies on regulations and preparing submissions. It outlines the growth potential within regulatory affairs and necessary skills such as being analytical and having strong writing abilities. The document also discusses where to learn about regulations from sources like the FDA and how to continue self-educating through networking and online courses.
LegoChem Bioscience is a Korean biotech company established in 2006 that uses its proprietary LegoChemistry platform to efficiently discover and develop novel small-molecule drug candidates. The company has built drug pipelines in antibiotics, anticoagulants, and oncology through independent research and collaborations. Its experienced team has advanced a new oxazolidinone antibiotic and FXa inhibitor to preclinical studies. LegoChem aims to initiate 5 clinical programs by 2012 and become an independent drug discovery and development firm.
Cultural Relationship between Quality of Drugs and Prevailing Regulatory Envi...Obaid Ali / Roohi B. Obaid
This presentation discusses the cultural relationship between drug quality and prevailing regulatory environments. It notes that drug quality has evolved from a moral obligation to real challenges, and asks whether the quality of drugs consumed by Pakistani citizens meets minimum global standards. The presentation expresses sincere concern over the quality of drugs used by citizens and asks why quality drugs are not available for Pakistanis. It questions how and who made the Drug Regulatory Authority of Pakistan incompetent, and suggests that if DRAP became competent, drug quality would improve. The presentation concludes by emphasizing the need to make decisions to protect one's loved ones and not allow lives to be put at risk by drugs that do not meet minimum quality standards.
The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses:
1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts.
2) Quality metrics and using data to understand industry performance and identify issues.
3) Shifting business models, including more outsourcing and the need for continuous quality improvements.
4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
Kirti Choksi has over 20 years of experience in quality assurance, regulatory, and compliance roles in the pharmaceutical and biotechnology industries. She has worked for companies such as Pfizer, Johnson & Johnson, and EUSA Pharma, where she managed quality reviews, audits, and ensured compliance with FDA regulations. Choksi's experience includes developing strategies, policies and procedures, as well as authoring documents like annual drug product review reports. She has expertise in areas such as GMP, GCP, clinical trials, and regulatory submissions to bodies like the FDA and EMA.
Speid & Associates provides consultancy services to help speed new drugs to market. They have a team of expert consultants with experience in regulatory affairs, clinical development, drug development, and other areas. Their services include strategic planning, preparing regulatory submissions, conducting due diligence, assisting with clinical trials, and training company staff. They work with clients around the world to help achieve successful global drug registration.
The document provides an overview of regulatory affairs as a career. It discusses why regulatory is an important and impactful field, the types of work involved including advising companies on regulations and preparing submissions. It outlines the growth potential within regulatory affairs and necessary skills such as being analytical and having strong writing abilities. The document also discusses where to learn about regulations from sources like the FDA and how to continue self-educating through networking and online courses.
LegoChem Bioscience is a Korean biotech company established in 2006 that uses its proprietary LegoChemistry platform to efficiently discover and develop novel small-molecule drug candidates. The company has built drug pipelines in antibiotics, anticoagulants, and oncology through independent research and collaborations. Its experienced team has advanced a new oxazolidinone antibiotic and FXa inhibitor to preclinical studies. LegoChem aims to initiate 5 clinical programs by 2012 and become an independent drug discovery and development firm.
Cultural Relationship between Quality of Drugs and Prevailing Regulatory Envi...Obaid Ali / Roohi B. Obaid
This presentation discusses the cultural relationship between drug quality and prevailing regulatory environments. It notes that drug quality has evolved from a moral obligation to real challenges, and asks whether the quality of drugs consumed by Pakistani citizens meets minimum global standards. The presentation expresses sincere concern over the quality of drugs used by citizens and asks why quality drugs are not available for Pakistanis. It questions how and who made the Drug Regulatory Authority of Pakistan incompetent, and suggests that if DRAP became competent, drug quality would improve. The presentation concludes by emphasizing the need to make decisions to protect one's loved ones and not allow lives to be put at risk by drugs that do not meet minimum quality standards.
The document summarizes a presentation on the pharmaceutical regulatory science landscape in 2015. It discusses:
1) Changes and emerging trends in regulatory sciences, including increased globalization and harmonization efforts.
2) Quality metrics and using data to understand industry performance and identify issues.
3) Shifting business models, including more outsourcing and the need for continuous quality improvements.
4) Ensuring data integrity and addressing challenges like lack of integrity raising doubts about safety.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
Kirti Choksi has over 20 years of experience in quality assurance, regulatory, and compliance roles in the pharmaceutical and biotechnology industries. She has worked for companies such as Pfizer, Johnson & Johnson, and EUSA Pharma, where she managed quality reviews, audits, and ensured compliance with FDA regulations. Choksi's experience includes developing strategies, policies and procedures, as well as authoring documents like annual drug product review reports. She has expertise in areas such as GMP, GCP, clinical trials, and regulatory submissions to bodies like the FDA and EMA.
Pass Regulatory Affairs Certification In First Attempt
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FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
BCIL (Biotech Consortium India Limited) is a public limited company established in 1990 under the Department of Biotechnology, Government of India to facilitate the commercialization of biotechnology. It works to transfer technologies and spearhead commercialization in areas like vaccines, diagnostics, and biopesticides. BCIL provides various services including technology transfer, project consultancy, certification, information services, biosafety management, and project management to support the biotechnology industry in India. It acts as an intermediary between technology developers and companies to facilitate successful transfer and commercialization of technologies.
This document discusses outsourcing bioanalytical work and provides guidance on contracting with external laboratories. It notes that 50% of R&D expenditures are external and clinical bioanalysis is outsourced at 90%. Reasons to outsource include flexible workforces, expertise, and GLP compliance. Aspects that can be outsourced include methods, sample analysis, and troubleshooting. Care must be taken in selecting qualified laboratories based on location, technical capabilities, people, culture, costs and quality systems. Managing outsourced work requires clear communication, site visits, and building relationships. Outsourcing can succeed by knowing why and what to outsource, selecting the right partners, and maintaining communication.
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The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013
Hal Siegel is an experienced regulatory affairs and scientific consultant. He has over 30 years of experience in regulatory affairs, medical product development, quality systems, and clinical affairs. He has held senior leadership roles at several companies, including Vice President and Chief Scientific Officer roles. He offers regulatory and scientific consulting services to help clients advance their programs efficiently and cost-effectively.
James D. Terish Bin has over 14 years of experience in the pharmaceutical industry, holding roles in analytical development, bioequivalence studies, quality management, and business development. He has a Doctorate in Pharmacy and has led teams of over 100 people, developing new services, growing businesses, and ensuring regulatory compliance. Currently he is the AGM of Operations at Sequent Research Limited, leading their bioanalytical and analytical services across multiple locations.
Global pharmaceutical & biotechnology outlook 2013 rising stars - Reports CornerReports Corner
Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-Biotechnology-Outlook-2013:-Rising-Stars/
This document provides an overview of the key responsibilities of sponsors and contract research organizations (CROs) in clinical trials. It discusses CRO responsibilities in areas such as regulatory affairs, project management, clinical operations, biometrics, medical writing, pharmacovigilance, and quality assurance. For each area, it briefly outlines some of the main tasks involved, such as regulatory submission and approval, clinical monitoring, statistical analysis, safety reporting, and ensuring compliance with Good Clinical Practice standards. The overall purpose is to define the roles that CROs take on to assist sponsors in managing various aspects of clinical research.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
The document outlines an agenda for a webinar on best practices for promotional content review. The webinar will cover what good promotional practices are, the importance of implementing them now, a four-step PACE process for content review, standard operating procedures for review, and a case study on tradeshow preparation. It includes slides on the key topics that will be discussed, such as establishing a cross-functional review committee and using categorization to ensure consistent application of review standards.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
- 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%.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
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.
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.
1) Regulatory affairs professionals play important roles in coordinating scientific efforts with regulatory needs throughout a product's lifecycle. They help companies reduce time to market and maximize resources.
2) Key responsibilities include evaluating marketing applications, issuing approvals, developing guidelines, inspecting sites, and monitoring drug safety.
3) In the pharmaceutical industry, regulatory affairs professionals develop regulatory strategies, prepare applications, maintain relationships with health authorities, and ensure compliance.
Pass Regulatory Affairs Certification In First Attempt
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RAC Past papers Dumps Available at Exams4sure.com
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FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
BCIL (Biotech Consortium India Limited) is a public limited company established in 1990 under the Department of Biotechnology, Government of India to facilitate the commercialization of biotechnology. It works to transfer technologies and spearhead commercialization in areas like vaccines, diagnostics, and biopesticides. BCIL provides various services including technology transfer, project consultancy, certification, information services, biosafety management, and project management to support the biotechnology industry in India. It acts as an intermediary between technology developers and companies to facilitate successful transfer and commercialization of technologies.
This document discusses outsourcing bioanalytical work and provides guidance on contracting with external laboratories. It notes that 50% of R&D expenditures are external and clinical bioanalysis is outsourced at 90%. Reasons to outsource include flexible workforces, expertise, and GLP compliance. Aspects that can be outsourced include methods, sample analysis, and troubleshooting. Care must be taken in selecting qualified laboratories based on location, technical capabilities, people, culture, costs and quality systems. Managing outsourced work requires clear communication, site visits, and building relationships. Outsourcing can succeed by knowing why and what to outsource, selecting the right partners, and maintaining communication.
Now you don’t need to take any stress about the RAC US Exam. We provide you real exam questions along with updated Test Engine. You can pass your exam in first attempt with 100% passing assurance and money back guarantee. Get amazing flat 15% discount on RAC US exam and pass your RAC US Dumps Exam. Visit us for more information and RAC US Exam Questions.
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The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
"Pharmacovigilance in Crisis: Drug Safety at a Crossroads, 2018".Rosmirella Cano Rojas
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers.
The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine- learning to automate pharmacovigilance operations.
These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013
Hal Siegel is an experienced regulatory affairs and scientific consultant. He has over 30 years of experience in regulatory affairs, medical product development, quality systems, and clinical affairs. He has held senior leadership roles at several companies, including Vice President and Chief Scientific Officer roles. He offers regulatory and scientific consulting services to help clients advance their programs efficiently and cost-effectively.
James D. Terish Bin has over 14 years of experience in the pharmaceutical industry, holding roles in analytical development, bioequivalence studies, quality management, and business development. He has a Doctorate in Pharmacy and has led teams of over 100 people, developing new services, growing businesses, and ensuring regulatory compliance. Currently he is the AGM of Operations at Sequent Research Limited, leading their bioanalytical and analytical services across multiple locations.
Global pharmaceutical & biotechnology outlook 2013 rising stars - Reports CornerReports Corner
Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-Biotechnology-Outlook-2013:-Rising-Stars/
This document provides an overview of the key responsibilities of sponsors and contract research organizations (CROs) in clinical trials. It discusses CRO responsibilities in areas such as regulatory affairs, project management, clinical operations, biometrics, medical writing, pharmacovigilance, and quality assurance. For each area, it briefly outlines some of the main tasks involved, such as regulatory submission and approval, clinical monitoring, statistical analysis, safety reporting, and ensuring compliance with Good Clinical Practice standards. The overall purpose is to define the roles that CROs take on to assist sponsors in managing various aspects of clinical research.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
The document outlines an agenda for a webinar on best practices for promotional content review. The webinar will cover what good promotional practices are, the importance of implementing them now, a four-step PACE process for content review, standard operating procedures for review, and a case study on tradeshow preparation. It includes slides on the key topics that will be discussed, such as establishing a cross-functional review committee and using categorization to ensure consistent application of review standards.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
- 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%.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
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.
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.
1) Regulatory affairs professionals play important roles in coordinating scientific efforts with regulatory needs throughout a product's lifecycle. They help companies reduce time to market and maximize resources.
2) Key responsibilities include evaluating marketing applications, issuing approvals, developing guidelines, inspecting sites, and monitoring drug safety.
3) In the pharmaceutical industry, regulatory affairs professionals develop regulatory strategies, prepare applications, maintain relationships with health authorities, and ensure compliance.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
Vedic Lifesciences is a contract research organization founded in 2000 that provides drug development services to pharmaceutical companies. It has managed over 34 clinical trials and 248 preclinical studies across multiple therapeutic areas. Services include regulatory submissions, clinical project management, data management, biostatistics, and medical writing. Vedic has experience in areas such as oncology, diabetes, orthopedics, andrology, and inflammation. It employs a team of experts including clinical researchers, medical writers, and regulatory specialists to support its clients.
A life sciences consulting firm based in Chicago, Aagami Inc., offers strategic consulting, technology licensing, and business/market research services to support global biotech, pharmaceutical, medical device, and consumer health companies in their initiatives with India and Asia. The document provides details on Aagami's services, approach, clients, leadership team, and case studies highlighting strategic partnerships and licensing deals facilitated by Aagami that helped clients establish partnerships and reduce costs in emerging markets.
Careers In Clinical Research Industry Gp 06 Nov11Gopalkrishna Pai
The document provides an overview of the stages involved in drug development from pre-clinical testing through clinical trials and regulatory approval. It outlines the various tests, studies and requirements at each stage, including in vitro and animal model screening, toxicity studies, pharmaceutical development, clinical trials in four phases, and post-marketing surveillance. It also describes the roles and requirements for different departments involved in clinical research.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
Following our past four highly successful events, this event focuses on “A Critical Guide for Successfully Conducting “6th Annual Clinical Trials Summit 2015” It gives me great pleasure in welcoming all of you to The Virtue Insight’s “6th Annual Clinical Trials Summit 2015”.
The document discusses how True Open Innovation and Boston Strategics' global network can improve drug development efficiency and lower costs. It outlines challenges in the pharmaceutical industry like decreased productivity and increased costs. It then describes how Boston Strategics uses a virtualized model and worldwide expert network to assemble project teams that can progress drug candidates through development faster and at lower expense than traditional models. Examples are provided of projects demonstrating savings of time and money. The goal is to establish an open innovation platform to facilitate drug development collaborations globally.
Get Your Development Program Started on the Right FootBrook White, PMP
You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.
Biotechnology, pharmaceutical, and medical device companies can partner with Cardinal Health Regulatory Sciences for additional resources and expertise throughout the biologics development process. Cardinal Health offers services including product development strategies, regulatory documentation preparation, facility inspections, and global regulatory strategies. Their experience includes over 100 product approvals across therapeutic areas. Partnering with Cardinal Health can help companies facilitate multinational approvals and achieve greater returns on development investments.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
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
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
How to Implement a Real Estate CRM SoftwareSalesTown
To implement a CRM for real estate, set clear goals, choose a CRM with key real estate features, and customize it to your needs. Migrate your data, train your team, and use automation to save time. Monitor performance, ensure data security, and use the CRM to enhance marketing. Regularly check its effectiveness to improve your business.
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
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2. Company Overview
Founded in 2007
Founder
Richard E. Lowenthal MS, MSEL
Sarina Tanimoto, MD, PhD
Office
San Diego, CA
Tokyo, Japan
London, UK (Partner, Sirius Consulting)
US Employees: 16 employees
2
3. Services
Comprehensive Therapeutic Product
Development Consulting (US/EU/Japan)
Regulatory Affairs and Quality Assurance
Auditing and Quality Management
Clinical and Pharmaceutical
Development
Biostatistics
Medical / Technical Writing
Electronic eCTD (IND/NDA/MAA)
Licensing
Due Diligence (Pharmaceutical,VC)
3
4. Consultant
Richard E. Lowenthal MS, MSEL
Main Past Positions
FDA New Drug Reviewer
Regulatory Affairs and Global Project Leader at Janssen
VP of Regulatory Affairs and Quality Assurance at Somerset,
AnGes, Maxim and Cadence
Acting Sr.Vice President at Jennerex Biotherapeutics and Auspex
Member of the Board at Momotaro Gene since 2012 (responsible
for all US operations)
Expertise and Experiences
Regulatory Strategy, Negotiation with Agencies
(FDA/EMEA/PMDA)
Biologics and Drugs: FDA, EMA and NIH/RAC
Participated in the filing and approval of 18 marketed products
4
5. Consultant
Sarina Tanimoto, MD MBA
Main Past Positions
MD, MPH, MBA, PhD
Nippon Roche (Clinical Development)
AnGes MG (Clinical and Business Development)
Founder PLC in the US and Japan
Expertise and Experiences
Clinical Development and Safety Monitoring for Drug
and Biologics
Japan MHLW Orphan Drug Designations
PMDA Negotiations and Meetings
Business Development in Japan and US
5
6. Pacific-Link Biologics Experts
Key PLC Experts on Biologics
Robert Bell PhD -
Biologics Manufacturing Expert
25 years Baxter and Barr; Member of USP Biologics Committee
Michael Hatfield, PhD – Biotechnology Development
Selective Genetics, Onyx, Jennerex; Extensive Analytical Expertise
Joyce Reyes, MSc RAC – Biologics Quality and Reg.
Invitrogen, Xoma, InterMune, Cell Genesis, Geron, Jennerex
Charles Olson, PhD – Biologics Manufacturing Expert
Bayer, Onxy, Biomarin, Cell Genesis, NextBio
Joseph Crea – Quality Assurance Expert
30+ years biologic qualify experience; Janssen, Iroko
Tracy Ross-Teichart, PhD - Nonclinical
6
7. Pacific-Link Key Partners
Sirius Regulatory
Consulting
EU Representative
Drug and Biotechnology
Development
Biotechnology GMP
Manufacturing
AccuReg Inc.
GCP Auditing and
Compliance
PEC and Omnicia
eCTD Software and
Filing Services
Duck Flats Pharma, Inc.
Phase I/II Specialty CRO
The Sage Group
High Level Business
Development
7
8. Key Areas of Expertise
Strategic Development for Biologics and
Pharmaceutical Products
Regulatory Interactions and Strategy for
US, Japan and EU (Global Development)
Project Management
Clinical Development and Site
Management
Business Development and Value
Maximization Strategies
Support of Due Diligence Reviews for
Companies and Venture Capital Groups
8
9. Experience
Support Multiple High Tech Companies
Jennerex – Oncolytic Viruses
Green Cross – Advanced Biologic Peptide
Momotaro Gene – Viral Vaccine Therapy
REGiMMUNE – Immune Regulatory Tehrapy
Other biologics utilizing cell based production
(NGM, Coheris, Polaris, I2O, iGM, )
Multiple Other Past and Present Clients
9
10. Biosimilar Expertise
Extensive expertise with the development
of advanced Biologic based products:
Complex proteins
Cell based therapies and production processes
Viral therapies and production processes
Regulatory experience with advanced
biologics in both CDER and CBER
10
12. Example: Momotaro-Gene Inc.
Full Project Management Responsibilities
Manufacturing Support in Liverpool England and Baylor
University
Managed GLP Toxicology Studies at MPI Research
Worked with Okayama University on Preclinical Program
Prepare and conduct Phase I trial
FDA Interactions and Consultation
Pre-PreIND Consultation Jan 2009 (design of Dev. Plan)
PreIND Meeting Nov 2009 (adjust Dev. Plan and IND)
Multiple informal discussions and consultations
NIH RAC Filed Jan 2010 : Public Meeting March 2010 :
RAC Approval March 2010
IND Filed March 1 2010 : Approved March 31
Conducting Phase I Clinical Trials in 2 indications
12
13. Example: Current Clinical Trials
Extensive Experience in Clinical Trial Management
Current Clinical Trials Under Management
Momotaro Gene (MTG-REIC-PC001), Green Cross (MG1102-01),
REGiMMUNE (RGI-2001-02) and others
Preparation
Write protocol: Develop Protocol with KOLs and Pis, Negotiate Protocol with
FDA, Obtain Scientific and IRB Approvals at Sites
Select sites: Evaluate Site qualifications, build relationship with investigators
Create documents: IRB related, CRF
Manage IRB Submissions and Approvals
Site initiation
Manage trial conduct directly through contract CRA and Data Management
Evaluate & negotiate proposals from CRO: Develop Trial Management Plan,
Budget, Responsibilities and Compliance requirements.
Management
Train site coordinator, monitor and pharmacy
Track enrollment
DSMB: chose members, organize charter and hold meetings
Manage conduct of CRO
13
15. Support for Innovators
Overall Project Management
Development Plans and Regulatory Support
What quality and studies are required for IND and MA
Pharm studies, Preclinical studies (incl. Tox) and Clinical
studies, what , where and when?
Risk assessment
Obtain advice from agencies regarding studies and
quality required
→Avoid unnecessary work and focus on necessary
studies to achieve key company milestones
Manage clinical trial
Consult with Agencies in VERY early stage
15
16. Support for BioPharmaceutical Companies
Senior Level Strategic Advice and Review of
Submissions.
Long Term Regulatory Liaison
Support/Emergency Support
Support Compliance and Production Processes
Prepare Clinical/Regulatory Documents
IND/BLA/NDA documents
Protocols, IB, SSP
Communication with Agencies
16
17. Support for VC
Due Diligence
Review Product Technical Details
Product Risk Assessment (Probability of
Success from a Technical Perspective)
Review Regulatory Pathway for FDA, EMA
and PMDA
Review of Development Plan and Cost
Estimates
Provide Strategic Advice to Venture Start-up
Companies
17
18. Quality Auditing and Management
Direct Auditing Expertise for both
Manufacturing and Clinical Sites
Richard Lowenthal formerly member of the
FDA GMP Committee during CFR 211
Rewrite of Regulations.
Expertise in GCPs and Clinical Audits
Partner Companies and Experts Available to
further Support Client Needs
Routinely Audit Biotech and Drug
Facilities
Routinely Audit Clinical Sites and Central
Labs
18
19. Support for Generic Business
Experience with Multiple ANDA Filings
and OGD procedures
Structured Templates that Meet OGD
Requirements
Relationships with OGD Staff
Capability to resolve potential issues prior to
submission
Able to negotiate critical points during review
Full Filing Capability Including Electronic
eCTD Capability
19
20. Support for US Operations
PLC routinely supports foreign
companies subcontracting in the United
States (US)
Direct supervision of contract facilities
GMP Production, GLP Nonclinical Studies
Manage CROs for Clinical Trials
PLC can subcontract to consolidate
contracting and management of US
Contractors
20
21. Safety Management
Medical Monitoring Capability
Clinical Site Management of Medical Issues
Collection of Safety Data
Central Medical Monitor Interpretation of
Events
Regulatory Reporting
SAEs
Annual Report
21
22. Support for Overseas companies
Overall Project Management
Development Plans and Regulatory Support
IND – NDA/BLA – Launch
Define what quality and studies are required each stage
Pharm studies, Preclinical studies (incl. Tox) and Clinical studies,
what , where and when?
Risk assessment
Product Development Support
Select manufacturing sites and support technology transfers
Build relationships with subcontractors
Conduct pre-qualification audits
Evaluated product development plans and data
Help managed US subcontract facilities
22
23. Support for Japanese Market
Overall Project Management
Development Plans and Regulatory Support
Orphan Drug Designation
Asian bridging trials
PMDA consultation for development
IND – NDA/BLA – Launch
Define what quality and studies are required each stage
Pharm studies, Preclinical studies (incl. Tox) and Clinical studies
Risk assessment
Clinical Development Support
Select clinical sites and prepare & conduct clinical trial
Build relationship with KOLs and investigators
Create protocol
Identify CRO and CRO management
DSMB management
Report writing
23