Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
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 Research Leadership Team – Four successfully launched peptide/protein…
Pharmaceutical Regulation, FDA Compliance & Inspections, Sterile Compounding, Quality Systems, and Regulatory Science
Expert is a board-certified pharmacist and regulatory science professional with over two decades of combined experience in pharmaceutical compliance, inspectional oversight, and sterile compounding practice. Throughout an extensive career with the U.S. Food and Drug Administration (FDA), Expert has conducted…
HPAPIs, Pharmaceutical
Imaginative and resourceful professional with multi-faceted leadership experience in project/program management and drug development and manufacturing. Possesses key business skill sets including: strategy planning and execution, new product development, negotiation and influencing, and continuous process improvement. Strong technical skills to…
Formulation Science, Formulation Chemistry
Expert is an experienced ‘Formulation Scientist’ offering outstanding Product Development skills for Oral Liquids, OTC Products, Hand Sanitizers, Personal Care Products, Topicals Products, Tablets, Parenteral Products. Expert can also help in modifying existing formula, offer expert guidance on product design,…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
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 conditions for…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Microbiological Contamination Control
A principal with his eponymous consulting firm, Expert has amassed 30 years of experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology,…
Lyophilization
Expert's career in the pharmaceutical industry spans over 20 years. His work has focused on the following: • Supervision of pharmaceutical plants and technological transfers. • Development and implementation of operational standard procedures related to manufacturing processes and quality control.…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
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 of Pharmaceutical Development Services and the Chief…