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.
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.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
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.
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.
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Warm Greetings from Chempro Pharma! Here is a brief presentation regarding our newest project/service offering - pharmaceutical product development. We have a highly specialized team that has worked with the likes of Novartis, Merck and many more market leaders within the pharmaceutical industry. Feel free to review this attachment and contact us at pharma@chemprogroup.net if you have any questions, thanks!
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
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.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
The fundamental importance of laboratory compliance means that it must be a core strategic priority for laboratory management. However, it is not uncommon for day-to-day job pressures and business priorities to limit strategic compliance thinking to being reactive, rather than proactive; this leads to those instances in which “inspection readiness” is not a strategic priority, but the work done just before the audit.
Shop to Fundraise creates health, wealth and prosperity for non-profit organizations. Originally founded as a way to support youth sports clubs, Shop to Fundraise will work for any non-profit organization. It is currently being supported by former NBA player, Jerome Williams; former NHL players, Randy Burridge, Jayson More, Pokey Reddick and Bob Sweeney; former U.S. Soccer professional, Eddie Henderson; and former professional Figure Skater, Surya Bonaly.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Warm Greetings from Chempro Pharma! Here is a brief presentation regarding our newest project/service offering - pharmaceutical product development. We have a highly specialized team that has worked with the likes of Novartis, Merck and many more market leaders within the pharmaceutical industry. Feel free to review this attachment and contact us at pharma@chemprogroup.net if you have any questions, thanks!
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
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.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Generic product development and technology transfer : At a glanceDr. Girish S Sonar
It’s honor to get invited as a speaker and to address “Pharma Formulation and Regulatory Symposium” organized by Merck Malaysia on 6th Sept, 2018 at Pullman Bangsar, Kuala Lumpur, Malaysia. The topic I presented was “Generic Product Development and Technology Transfer: At a Glance”. Scientists and industry experts from 31 Malaysia Pharma companies and Universities attended this symposium. The presentation covered challenges and remedies come across from product development to approval from regulatory agencies.
Pleasured to share desk with Dr. Torsten Schadendorf, Marketing Manager Merck Germany, Dr. Gudrun Birk, Head of Controlled Release, Merck Germany and Professor Tin Wui Wong, Universiti Teknologi MARA, Malaysia.
The fundamental importance of laboratory compliance means that it must be a core strategic priority for laboratory management. However, it is not uncommon for day-to-day job pressures and business priorities to limit strategic compliance thinking to being reactive, rather than proactive; this leads to those instances in which “inspection readiness” is not a strategic priority, but the work done just before the audit.
Shop to Fundraise creates health, wealth and prosperity for non-profit organizations. Originally founded as a way to support youth sports clubs, Shop to Fundraise will work for any non-profit organization. It is currently being supported by former NBA player, Jerome Williams; former NHL players, Randy Burridge, Jayson More, Pokey Reddick and Bob Sweeney; former U.S. Soccer professional, Eddie Henderson; and former professional Figure Skater, Surya Bonaly.
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
High Quality Integrated Drug R&D Servicesmedicilonz
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
Established in 2012, EFRAC is a USFDA Inspected & BSE Listed Company having ISO
17025:2005 Accreditation in Chemical & Biological disciplines. Drugs & Cosmetics Division at
EFRAC is and advanced Pharmaceutical Testing Facility with Cutting-Edge Technology, 21 CFR Part
11 enabled & DQ, IQ, OQ, PQ, Qualified Instrumentation. EFRAC conducts a wide range of Tests in
Strict adherence to the Scientifically Approved Protocols and Standards by Drug Regulators like
CDSCO, WHO, MHRA & USFDA.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Kuecept Ltd was founded in 2007 by a group of experienced industrial scientists to provide customised R&D solutions and consultancy services to the pharmaceutical, biotech and health-care industries.
Today, we are one of a few contract research organisations dedicated solely to providing preformulation, formulation development and enabling drug delivery services to companies in the discovery / preclinical stages. By working exclusively in this field, we have developed a wealth of knowledge and expertise of enabling drug delivery technologies and formulation know-how in drug solubility and bioavailability enhancement and with over 600 projects completed to date on over 250 NCEs, are well placed to help resolve some of the most complex drug development issues.
Our experience covers a broad range of discovery, development & related activities supporting oral, parenteral and orally / nasally inhaled drug products.
Fully-Integrated Services for Global Therapeutics Development: Accelerating Progress and Time to Market with integrated CDMO Platforms and Laboratory Testing Services. WuXi Advanced Therapies leverages decades of laboratory testing experience to get your product to market faster and with greater predictability, by overcoming common industry constraints.
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
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
2. We are all in the business of improving the quality of human lives. Each of us, whether client or service provider, are joined in the commitment to reach critical milestones faster, deliver clinical materials on time, control costs, and above all to ensure quality. At Xcelience, we call this Molecular Responsibility™, the commitment to hold ourselves to ever-increasing high standards of quality, service performance, and drug development expertise that in turn enable our clients to overcome drug development challenges and improve chances for compound success. Partnering with a specialist like Xcelience for early phase development can significantly reduce product risk and accelerate drug development timelines. We are early drug development made easy – at last.
3. Core Competencies API Characterization Polymorph Screening, Salt Screening, Drug Product Characterization Analytical Services Method Development and Validation, Waters and Agilent Instrumentation Dosage Form Development and Manufacturing Solids, Semi-solids, Liquids Manufacturing, Packaging and Labeling Direct Fill API into Capsules Matching placebo formulation Creation and qualification of blinded reference product Process qualification Technology transfer Process optimization Blister Packaging Stability Program Management Broad variety of temperature and humidity conditions
8. API into capsule projects are on average completed 45% faster than traditional formulation development efforts, and in some cases have enabled our clients to shave from 13 to as much as 17 weeks from total development time.
13. Preformulation Services Solid Characterization Drug Substance Characterization Thermal information X-ray Powder Diffraction Particle size Moisture Content Morphology Salt Selection screening Polymorph screening Purity determinations Solid-state stability Photostability Intrinsic Dissolution Reference Standard Qualifications Solution Characterization Drug substance evaluation pKa determination Partition and distribution coefficient pH Solubility profile Other Services Excipient compatibility Accelerated stability (ICH conditions) Chiral Stability
14. Analytical Services Method Development, Qualification, and Validation Raw Material Testing (Selected) Stability Sample Analysis Dissolution Testing Residual Solvent Analysis Chiral Determination Cleaning Evaluations Technical Packages for Drug Substances
15. Formulation Development Solids Tablets, capsules, sustained release, coatings Semi-Solids Ointments, creams, gel Dispersed Systems Emulsions, suspensions Liquids Orals, ophthalmic, parenterals
16. Formulation Development for Poorly Soluble Compounds Conventional Formulations/Processes Use water soluble excipients Micronize the API pH modifiers citric acid, succinic acid etc Solubilizing/wetting agents sodium laurel sulfate, Tween 80 Alternate Processing Add drug to aqueous granulating solution containing wetting/solubilizing agent Dissolve API in hydroalcoholic/ alcoholic granulating solution May alter API characteristics Form Solid dispersion/solution in hot melt process using CFS1200™ Complexing agents (Cyclodextrins) Liquid fill hard gelatin capsule
17. Manufacturing Manufacturing Tablets and capsules API in a capsule Liquids in a capsule Suspensions Emulsions Semi-solids Non-sterile liquid Reference Product Blinding Packaging and Labeling Expertise Creation of matching placebo formulation Creation and qualification of blinded reference product Process qualification Technology transfer Process definition optimization
38. Convenient Location Tampa, Florida Location Laurel Facility (24,000 ft2) cGMP Compliant FDA Inspected 2008, December (PAI) 2006, June (General Systems) 2003, August (General Systems) DEA Schedule License 2007, October II to V Manufacturing I to V Analytical
39. Why Xcelience? Quality-First Focus Three FDA audits (2008, 2006, 2003) with the last being a PAI Numerous client audits/year reinforce compliance with latest regulations Low staff turnover Speed Accelerated drug development programs to meet critical milestones Strong on-time project completion record Agility Cross-training program for pharmaceutical development staff Flexible manufacturing model, dedicated equipment Technology Market leadership for Powder-in-Capsule programs with Xcelodose® precision powder micro-dosing systems Expanded process technology capabilities designed to deliver improved manufacturing outcomes in a manner consistent with QbD Cutting edge preformulation technology including the XRD for polymorph screens, salt screens, and crystallinity determination Blister packaging with tooling design for a wide variety of dosage forms Expertise Ability to attract top talent with successful drug development track records More Xcelodose™ experience than any other CRO, >100 APIs, >130 batches Partnership Unique project team structure feel likes an extension of client facility Leveraging size to our advantage to provide personal attention