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Active Pharmaceutical Ingredient Experts

The following experts are available as active pharmaceutical ingredient consultants and active pharmaceutical ingredient expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Active Pharmaceutical Ingredient - The substance in a drug that is pharmaceutically active.

Synonyms:  API

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1 to 25
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Active Pharmaceutical Ingredient Experts
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Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile

Netherlands

Expert in Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles to the ... See full profile

Germany

Expert in FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile

Michigan (MI), USA

Expert in Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section of these summaries under the ... See full profile

India

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 Catalysis, Refining & Petrochemical Processes, Biofuels
Expert has recently worked on commercializing a biomass to transportation fuel process for a start-up that produced almost 1 million gallons of a drop in fuel at Expert's Firm His work increased the predicted yields of the next generation process by 10% and saved ... See full profile

Texas (TX), USA

Expert in Nutrition Labeling Laws and FDA Regulations, Nutritional Genomics, Disease Prevention, DHA
Expert has been a researcher, consultant and teacher of nutrition at some of the most prestigious medical institutions in the country. She is the Director of the Nutrition Information Center. Her research focus currently centers on the nutritional ... See full profile

New York (NY), USA

Expert in Molecular Psychiatry and Neuroscience, Neuropharmacology, Cancer Immunotherapy
Expert has combined his extensive expertise in molecular biology, immunology, molecular neuroscience and psychiatry, and cancer biology to develop a new avenue in the discovery of suitable molecular targets for complex treatment of neurodevelopmental ... See full profile

United Kingdom

Expert in Specialty Chemicals,Pharmaceuticals, Nutrition, Composites,Synthetic Resins, Engineering Plastics
Mr. N.V.Expert has over 10 years of operational, business, strategic and executive leadership experience in this area having run DSM's pharmaceutical businesses in this area; he also led the Ant-Infectives business in the Asia Pacific, Middle East and ... See full profile

Haryana, India

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile

Québec, Canada

Expert in Chemistry, Crystallography, Crystalline Solids, Polymorphism, Hydrates and Pharmaceuticals
Expert has extensive experience in research on crystalline molecular solids, X-ray and neutron crystallography, coordination chemistry and supramolecular chemistry (RSC Meldola Medal; Bob Hay Lectureship; Corday-Morgan Prize). See full profile

United Kingdom

Expert in Pre-Clinical Pharmacology, Drug Discovery to IND
Expert has been a member of the Faculty of a UK university medical school for 21 years. He is Director of the Cellular and Molecular Neuropharmacology Research Group. The group's principal research interest is 5-HT (5-hydroxytryptamine, serotonin) and ... See full profile

United Kingdom

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 Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical ... See full profile

New York (NY), USA

Expert in Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS, CBE-30. See full profile

California (CA), USA

Expert in Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. See full profile

Illinois (IL), 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 Surgical Ophthalmology, Eyecare, Cataract/Refractive Surgery, Future Trends
Expert, MD has been in practice for twenty years as a comprehensive ophthalmologist. He specializes in cataract and refractive surgery but is well-versed in all areas of general ophthalmology. As a partner in one of the premier ophthalmology practices ... See full profile

Michigan (MI), USA

Expert in Chemical Patent Searching, Markush Structure Searching, General Chemistry, Biotechnology
Expert has thirteen years experience performing patent searching for pharmaceutical and agrochemical active ... See full profile

Delaware (DE), USA

Expert in Biopharmaceutical Processes
Expert has a BSc. in biotechnology from London (Imperial College) & a Ph.D in cell physiology from Liverpool (UK). Expert has over 20 years experience gained in a wide range of companies in the pharmaceutical and biopharmaceutical fields. See full profile

CO. Kildare, Ireland

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, ... See full profile

Maharashtra, India

Expert in Pharmaceutical Process Research, Development, and Manufacturing
Expert has 17 years experience of research, development and manufacturing of APIs. Expert has three patents from research, development and manufacturing of etoposide and etoposide phosphate. He also has extensive experience with platinum ... See full profile

Pennsylvania (PA), USA

Expert in Specialty and Fine Chemicals, Pharmaceuticals, Resins, Coatings
He has worked in the process development, manufacturing related to the technologies, chemistries. He has also worked in intellectual property strategy, commercialization of many different technologies. He is able to do this as he has cross- fertilized ... See full profile

Ohio (OH), 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 Process Chemistry: R&D, GC, HPLC, Flash Chromatography, NMR, IR, Mass Spec, & LCMS, Synthetics
He has experience with process research and development, including scale-up to 10- and 15-L reactors. Included in his background is experience with the design, execution, and optimization of multi step organic syntheses aimed at both pharmaceutical ... See full profile

California (CA), USA

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