ForensisGroup drug manufacturing expert witnesses are knowledgeable and have significant backgrounds in the FDA patent approval process, as well as experience in drug development, clinical manufacturing, and drug delivery systems.
Our expert witnesses have been involved in all aspects of drug product development: sterile product subject matter, peptide and protein formulation, drug delivery, aseptic processing, sustained release parenteral, excipients, inter partes patent review, technology transfer, injection devises, solubilization, and patent infringement and validity. Some of these experts are specialists in the pharmaceutical packaging regulations and processes, and some with extensive experience in laboratory management, biotechnology, clinical development, compound evaluation, dosage forms, drug regulatory affairs, facility compliance, and the FDA drug approval process.
Our specialists lend their expertise to consulting on laboratory and manufacturing audits, drug and medical device licensing, medicine in the media, microbiological development, as well as pre-clinical and clinical studies, and production monitoring.
Their professional experience includes various technical management positions in quality control, technical service, labeling, and in research and development in pharmaceutical companies. Many have worked with extensive FDA interactions, as FDA trainers, and in biopharmaceutical formulation and stability.
ForensisGroup can provide you with the CVs and fee schedules of highly reputable drug manufacturing experts. Your initial case consultations with select expert witnesses, prior to retention, are complimentary. Contact us today to be connected with the right expert for your case.