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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…
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 department at Altus Pharmaceuticals…
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…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
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…
Infusion Center Expert, Hospital Infusion, Ambulatory Infusion Center, Phamaceutical Product Advisor
The infusion center business is highly complex; thin margins, adverse selection of patients, and challenging economic conditions can drive a potentially profitable business toward financial losses. This expert's firm has years of experience optimizing processes and procedures at new and…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., 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, with special focus on drug delivery platforms and drug-device…
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 problem solving. Expert has expertise in the fields of…