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Chemistry, Manufacturing and Controls


advanced process control


pharmaceutical manufacturing facility auditing


pharmaceutical technology


pharmaceutical product development


pharmaceutical quality control


Chemistry, Manufacturing and Controls Experts

The following experts are available as Chemistry, Manufacturing and Controls consultants and Chemistry, Manufacturing and Controls expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Chemistry, Manufacturing and Controls - The part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and the manner by which the manufacturing process is shown to be in control.

Synonyms:  CMC

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Expert in All Aspects of Quality and Regulatory Support for FDA Regulated Drugs, Biologics and Devices
Advisor on technologies, production, regulatory affairs and quality compliance to senior management of companies producing biologics, medical devices, and pharmaceuticals, in the U.S., Germany, France, England, Sweden, Israel, Japan and China. See full profile

New York (NY), USA

Expert in Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, ... See full profile

California (CA), USA

Expert in Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. See full profile

Florida (FL), USA

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, ... See full profile

Kent, United Kingdom

Expert in Pharmaceutical, Nutraceutical & Cosmetic Manufacturing
Expert has extensive experience with the Pharmaceutical, Dietary Supplement and Cosmetic manufacturing processes. Expert has been most efficient in providing compliance, process optimization and cost control guidelines through documented implementation. See full profile

New Jersey (NJ), USA

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of ... See full profile

Massachusetts (MA), USA

Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile

New Mexico (NM), USA

Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor ... See full profile

Virginia (VA), USA

Expert in Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President ... See full profile

Florida (FL), USA

Expert in Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS ... See full profile

California (CA), USA

Expert in Biopharmaceutical Development
Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most ... See full profile

Massachusetts (MA), USA

Expert in Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. See full profile

Berkshire, United Kingdom

Expert in Process Design
Expert is founder and president of a Houston based process engineering and project management firm focusing on petroleum refining, chemical, and gas processing industries. Expert has 25 years of experience involving process design, process ... See full profile

Texas (TX), USA

Expert in Corrosion and Metallurgical Failure Analysis
Expert notes that corrosion is a major problem that affects many industries. Expert has spent over forty years studying and solving corrosion problems in the construction, aerospace, defense, petroleum, utility and related industries. He was also the technical ... See full profile

Florida (FL), USA

Expert in Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical ... See full profile

Ohio (OH), USA

Expert in Global Procurement, Chemical Engineering, Manufacturing, Chemicals, International operations,
With over 17 years of experience managing new product development teams, Expert is currently Vice President of Research and Development for Chromatic Technologies. He is responsible for strategy, the new product pipeline, project management, resource ... See full profile

Colorado (CO), USA

Expert in Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. See full profile

California (CA), USA

Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence
Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, ... See full profile

Illinois (IL), USA

Expert in Bioprocess Development
Expert specializes in the development and selection of recombinant protein expression platforms, translating discovery candidates into development programs and the generation of preclinical material. She has successfully built infrastructure, ... See full profile

Massachusetts (MA), USA

Expert in Biodegradable Systems for Controlled-Release Drug Delivery
Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry ... See full profile

California (CA), USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), USA

Expert in Pharmaceutical Development, Design of Experiments
Expert has spent many years applying organic chemistry to solving problems in the fine chemicals and pharmaceutical industry. Expert has been involved for many years in developing chemical processes for the fine chemical and ... See full profile

Oregon (OR), USA

Expert in Medicinal Chemistry, Organic Chemistry, SAR Study, Making Library of Compounds, Drug Discovery
Expert has a very good experience in Medicinal Chemistry division of drug discovery research. He has been working in this field from last 10 years and has published several scholarly articles. He has more than 30 invention of disclosure ... See full profile

California (CA), USA

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