BioDelivery Sciences is a specialty pharmaceutical company focusing on pain management and addiction medicine.
I have more than 35 years of experience in the Pharmaceutical Industry and over 25 years of this time has been in Regulatory Affairs. I have filed NDAs (both 505(b)(1) and 505(b)(2) applications), INDs, ANDAs, AAs, and 510(k)'s working with drugs, biologics and devices during this time. I have experience with solid oral dosage forms, liquids, creams, ointments, sterile products (including solutions, suspensions and freeze dried powders), therapeutic proteins and cell based therapies. I have therapeutic area experience in several disciplines including metabolism and endocrine, cardiovascular, analgesia, dermatology and CNS. Additionally I have had responsibilities in Pharmacovigilance and Quality Assurance, including being responsible for FDA inspections in both of these technical disciplines.
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