RPI is pleased to introduce our experienced team of Chemistry, Manufacturing and Controls (CMC) experts.
RPI can provide you with comprehensive technical, compliance and writing support services for all of your CMC requirements at all stages of drug and biopharmaceutical development. We have extensive experience in CMO selection and management for small-molecules and biologics for many types of drug substances and all forms of drug products including aseptic fill and finish. Specialty areas include protocol development and reports for the validation of analytical assays, utilities, equipment and processes, OOS investigations, deviation reporting, specification justification stability (including formal stability shelf life projection reports) and development histories. We also offer GMP Quality Assurance and compliance support appropriate to the stage of drug development including SOPs, Test Methods, and facility and laboratory audits and can assist you in preparing for a pre-approval inspection.
Read more about our CMC experts below:
Ramon Burns, Ph.D.
Ramon has over 25 years’ experience in the development, manufacture and control of pharmaceutical products. He started his career at Syntex in parenteral product development and held pharmaceutical and analytical chemistry management positions at Collagen Corporation and Celtrix Pharmaceuticals. Ramon started consulting in 1995 and has worked on a wide variety of projects since involving cost effective, high quality report preparation, data analysis, and scientific or manufacturing process troubleshooting. Ramon is a six-sigma black belt whose technical expertise ranges over assay validation, stability (including formal stability shelf life projection reports), specification justification, and OOS/OOT auditing/root cause analysis. Specialized writing project completed include process descriptions, technology transfer reports, CTD section writing, development history reports, and method comparability reports. Ramon holds a BA degree in Biophysics from the University of Pennsylvania and a PhD in Chemistry from the Massachusetts Institute of Technology.
Robert Lopez
Robert has over 30 years experience in the development, manufacture and registration of biopharmaceuticals. His career started in medical devices and he subsequently held director level positions in a number of biotechnology companies including Genzyme, Genetics Institute, Celtrix and Telik. As a consultant Robert has specialized in CMO project management for biologics and aseptic products, performing activities such as proposals and contracts, budgets, project timelines, SOP and batch record generation and review, batch release, clinical supply logistics, Person in the Plant and on the floor Manufacturing Quality. Robert holds a BS in Medical Microbiology from San Jose State University.
Malcolm McKay, Ph.D.
Malcolm has over 30 years of GXP Compliance and Regulatory Affairs experience in the pharmaceutical industry. He started his career at Abbott Laboratories and later held senior Quality Assurance and Regulatory Affairs positions at a number of small-to-medium companies including Triton Biosciences, Berlex Biosciences, Celtrix Pharmaceuticals, COR Therapeutics, Cell Genesys, InterMune and Vivus. His strategic, tactical and technical experience comes from working with small molecules, peptides and biologics for a variety of dosage forms that involved the successful submission of dozens of CMC dossiers for INDs, BLAs, NDAs and MAAs. Malcolm holds a BS degree in Biology from Portsmouth University and a PhD in Biochemistry from King's College, London.