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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 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 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 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 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 World Wide Web, Hypertext Languages, etc.
Internet. Expert has developed and maintains a list of Internet resources related to the field of computer-mediated communication (CMC). He has created techniques for formatting, designing, and presenting this information in ... See full profile

Wisconsin (WI), 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 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 High ROI and Creative Strategic Business Planning and Implementation
As a Certified Management Consultant (CMC), Expert has been consulting with smaller businesses for over ten years to assist them in achieving their goals for profitability and growth. This includes providing consulting on business ... See full profile

California (CA), USA

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 Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation ... See full profile

New Jersey (NJ), USA

Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument ... See full profile

Massachusetts (MA), USA

Expert in Learning & Training Development for Organisations
Expert has trained instructors, trainers and facilitators working in the Oil and Gas industry for the last 6 years. He has developed a comprehensive developmental program for active instructors that they believe have enhanced their instructor / Trainer / ... See full profile

United Kingdom

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. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development
Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated ... See full profile

California (CA), 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 Surface Coating & Materials Technology CVD Chemical Vapor Deposition CVI Chemical Vapor Infiltration
He has over 25 years experience in the field of chemical vapor deposition. He has designed and built CVD coating systems up to 1.5m diameter & 2m high. He has a particular experience in high temperature (1200 - 2200 degC) CVD processes and design of ... See full profile

Bucks, United Kingdom

Expert in Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition of ... See full profile

New Jersey (NJ), USA

Expert in Strategy, Operations, Productivity & Industry Practices, Procurement, Logistics, Private Label
Expert has performed a wide range of assignments in the areas of strategic planning, marketing, logistics, retailing, operations, pricing, organization, productivity improvement, data processing and research. Clients have included manufacturers, ... See full profile

Connecticut (CT), 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 Program Management, Export Compliance (ITAR & EAR), Communications Systems Engineering
Expert has more than 20 years experience in success and profitable international projects in the aerospace and defense industry. In addition, he holds the Project Management Professional (PMP) certificate from the Project Management Institute. See full profile

California (CA), 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/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 Business Performance Improvement and Strategic Technology Planning
In 1999, Expert's Firm originated its flagship service called Rapid Transformation (RT). In its basic form RT combines the skills of Business Process Management with Information Technology, Strategic Planning and Human Resources . 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

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