Prasad Gullapalli, Ph.D.
Senior Drug Product Consultant
Dr. Gullapalli is skilled in the development and execution of CMC strategies for New Chemical Entities (NCEs) and for product line-extensions of existing molecules using patentable novel drug delivery technologies. He has over 20 years of experience developing strategies to respond to agency drug product inquires and representing clients during Preapproval Inspections (PAI), conducting investigations on Quality Events (QEs), and implementing Corrective and Preventive Actions (CAPAs).
- Built in-house oral dosage formulation and process development capabilities and personnel expertise (drug substance (DS) characterization, pre-formulation, analytical, and clinical & preclinical formulations) to complement the outsourcing model of early to late-stage product development and cGMP manufacturing at CROs & CDMOs,
- Expertise in immediate/Controlled Release (IR/CR) Tablets & Capsules, liquid-filled soft gel & hard capsules (SEDDS/SMEDDS/aqueous & nonaqueous solubilized dosage forms), and nanocrystal dispersions (NCD),
- Hands-on experience in both Biotech/Pharma and Contract Research Development & Manufacturing Organization (CRO & CDMO) sides of drug product (DP) development, selecting CROs & CDMOs, negotiating timelines and logistics and providing oversight (person-in-plant) of all supply chain management activities for clinical programs.
Before joining DSI, Dr. Gullapalli served as Head of Formulations at Dart Neuroscience and similar roles with Elan, Chiron and Purdue Pharma. He is RAC certified and earned his Ph.D. in Pharmaceutics from the University of Tennessee. He has eleven Patents/Applications and over 30 Publications/ Presentations.
- Oral Dose Formulation
- Process Development
- Person in Plant
- CMO Selection
- Supply Chain
- Clinical Trial Material
- Commercial Manufacturing
- Gastro-Retentive CR