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Active Pharmaceutical Ingredient Experts| The following experts are available as active pharmaceutical ingredient consultants and active pharmaceutical ingredient expert witnesses. Intota 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
(of 99) | | | Active Pharmaceutical Ingredient Experts |
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Expert Quote | | |  | | 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 GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
I am a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; I 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 1998; Bob Hay Lectureship 2008; Corday-Morgan Prize 2010). 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 ... 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 Product Development, Product Safety, Product Testing, Claims Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile | | Arizona (AZ), 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 patent from research, development and manufacturing of etoposide and etoposide phosphate. He also has extensive experience with platinum ... See full profile | | New Jersey (NJ), 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 | | | |  | | Expert in Pharmaceutical Development, Analytical Methods, Method Validation and GMP/Part 11 Compliance
Expert has been involved with cGMPs since their re-release in March 1979. For 7 years during his tenure at Roche he was Compliance and Training Officer for the Technical Development and Kilo Lab Departments, and developed schemes by which the Pilot Plant ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Managing the Interface between Owners and Engineering Contractors
Expert has successfully directed engineering and construction projects with values up to $700 million, primarily in the U.S. Working directly for the Owner, he most recently completed a $200 million project, 5% under budget and 2 months ahead of schedule, ... See full profile | | Connecticut (CT), USA | | | |  | | Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. See full profile | | California (CA), USA | | | |  | | Expert in Pharmaceutical Dosage Forms, Delivery of Poorly Soluble Drugs, Nanotechnologies
Expert is an expert in delivery of poorly soluble drugs. He has 15+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to ... See full profile | | Oregon (OR), USA | | |  | | >> Next 25 Experts
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