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drug screening

drug discovery

animal drug testing

employee drug testing

drug blood level determination

medical diagnostic test

driving under the influence testing

active pharmaceutical ingredient

investigational drug procedures

bioinformatics

bioethics

molecular diversity

combinatorial chemistry

pharmaceutical technology

animal disease model

drug formulation

rational drug design

mouse surgery

drug metabolite

blood testing

urine control sample

drug validation

drug clinical trial

drug processing

drug toxicology

pharmaceutical research

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 Formulations, Nutraceutical Formulations
Expert is an expert in developing multi-source drug formulations and generic equivalents of innovator products. To date, he has developed and put into the international market more than 100 such ... See full profile

India

Expert in Drug Delivery, Formulation Development of NCE's, Preformulation, Stability, Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral ... See full profile

California (CA), USA

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 Medicine, Especially Pathology (Laboratory Medicine), Women's Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has ... See full profile

New York (NY), USA

Expert in Addiction in Pain Patients, Clinical Research, Analgesia, Neuroscience, Nursing, Sedatives, Morphine
Expert has expert knowledge of the different classes of abused drugs (including alcohol), both their unique clinical pharmacology and their shared effects on neural reward and memory systems. Specifically, she can speak on the neurochemistry and ... See full profile

California (CA), USA

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 Delivery, Drug Development, Business Development, IP Strategy, Medical Nanotechnology,
As a business development exectuive and as CEO of several life sciences companies, he has had the opportunity to be closely involved and lead the identification, negotiation and closing of a number of licensing and R&D agreements with pharmaceutical, ... See full profile

North Carolina (NC), USA

Expert in Forensic Science, Toxicology, DNA Analysis, Food Poisoning, Toxic Torts
Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Applied Toxicology. Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Biotoxicology. Part of his research entails ... See full profile

Texas (TX), USA

Expert in Hatch-Waxman patent litigation, CMC Pharma Dev Issues, Preformulation/Formulation, Regulat-Reports
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal ... See full profile

Florida (FL), USA

Expert in Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product ... See full profile

Florida (FL), USA

Expert in Statistical Consulting, Biostatistics, Statistical Support to Litigation
Expert has over 13 years experience as statistician and Director of Biometrics in the pharmaceutical industry. In addition, he has 8 years experience as a Professor of Statistics at the University of Florida. Expert served as functional ... See full profile

Pennsylvania (PA), USA

Expert in Design and Conduct of Clinical Trials for Oral Healthcare Products
Expert is a trained periodontist with a career in both academics and industry. He was the senior director of dental affairs and new technology at Warner-Lambert (later Pfizer) consumer health products R&D for close to 15 years. See full profile

New Jersey (NJ), USA

Expert in Pharma Analytical Development, Stability, and QC Lab operations
Extensive use of various analytical techniques for qualitative and quantitative evaluation of small and large molecule compounds. Written many procedures describing in detail how the technique works and how it is to be used with various sample matrices. See full profile

Illinois (IL), USA

Expert in Sodium Bicarbonate Chemistry Including Effervescence, and Pharmaceutical and Pesticide Chemistry
Expert was the Senior Manager of Technical Services and Applications Development for Church & Dwight Company for more than 25 years. In that capacity he developed and commercialized new products based on bicarbonate chemistry, ... See full profile

New Jersey (NJ), USA

Expert in PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all ... See full profile

North Carolina (NC), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

New Jersey (NJ), USA

Expert in Statistics and Data Management; Pharmaceutical Industry
Expert has vast experience in the field of pharmaceutical development. He has been responsible for managing all quality laboratories, and product quality assessment and release to market. He has also evaluated process and product data for 54 drug ... See full profile

Illinois (IL), USA

Expert in Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development
Expert has worked in the biotechnology industry for more than 24 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, ... See full profile

California (CA), USA

Expert in Pharmaceutical Product Development, Drug Safety, Regulatory Affairs, Due Diligence
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

Northamptonshire, United Kingdom

Expert in Pharmaceutical Manufacturing
Expert career as a senior executive in the pharmaceutical manufacturing industry spans over 25 years and includes experience and understanding of every facet of the manufacturing process, in addition to strong skills in technical, operational ... See full profile

California (CA), USA

Expert in Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. See full profile

Pennsylvania (PA), USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), 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 Recombinant Protein Expression/Production, Molecular Biology
Through an 18 year career at California Biotechnology, Scios Inc., and Johnson & Johnson, Expert has gained extensive experience in the molecular biology of recombinant protein production especially in microbial systems such as E. See full profile

California (CA), USA