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drug validation

validation

active pharmaceutical ingredient

investigational drug procedures

abbreviated new drug application

bioinformatics

molecular diversity

combinatorial chemistry

European drug registration

drug product approval

drug formulation

drug clinical trial

pharmaceutical research

drug development

drug analysis

drug regulation

process validation

drug

pharmaceutical manufacturing

drug screening

Expert in Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher Institute (FMI; ... See full profile

Switzerland

Expert in Intellectual Property, Licensing, Biopharma, Pharma, Medical Devices, Chemisty
Expert has more than 20 years of expertise in intellectual property, transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, ... See full profile

Colorado (CO), 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 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 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 Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological ... See full profile

New Jersey (NJ), USA

Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. See full profile

Oregon (OR), USA

Expert in GMPs for Drugs, Devices, Biologics
The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. See full profile

Minnesota (MN), USA

Expert in Pharmaceutical Process Validation & FDA Compliance
Expert is an expert in industrial pharmacy and pharmaceutical process validation. He understands the technology of transferring laboratory pharmaceutical formulations into successful pilot production processes, and high volume production ... See full profile

New Jersey (NJ), 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 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 Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant ... See full profile

Illinois (IL), USA

Expert in Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials ... See full profile

California (CA), USA

Expert in Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile

Michigan (MI), USA

Expert in Genomic Technologies, Bioinformatics, Computational Biology and their Applications
Expert completed is PhD in theoretical physics and two years as a postdoctoral fellow in physics before receiving a five-year fellowship to work on the Human Genome Project. He began working on genome mapping at the Salk Institute in 1992, ... See full profile

Massachusetts (MA), USA

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 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 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 Regulatory Compliance Auditing, Training; FDA NDA/ANDA and DEA QA and Drug Inspections, Approvals
Expert is an internationally recognized authority on GMP and ISO auditing. In 1984 he authored the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. In use by over 8000 companies worldwide, and translated into ... See full profile

Illinois (IL), 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 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 Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run ... See full profile

Suffolk, United Kingdom

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 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