Anil Raghani, Ph.D.
Senior Analytical Development Consultant
Dr. Raghani is a seasoned pharmaceutical professional with area of expertise in analytical chemistry related to Chemistry, Manufacturing, Controls (CMC) Module 3/Quality, technical writing for regulatory submissions, analytical method development, validation, technology transfer and control strategy development. An accomplished Consultant with in-depth understanding of manufacturing process development of small molecule therapeutics as well as biologics, formulation development, raw material control, regulatory requirements and ICH guidelines. Dr. Raghani is highly experienced in reviewing scientific information from laboratory data, technical reports, quality and manufacturing documents to assess technical merits and suitability of scientific rationale to ensure information presented in the regulatory submission is presented clearly and conclusions are supported by the scientific data.
- Develops analytical methods with universal set of analytical conditions that provide a unified approach for the implementation across multiple products
- Authors analytical sections of (INDs, BLA and MAA) and numerous RTQs
- Experienced in Biologics; protein characterization, analytical comparability and biosimilarity
Dr. Raghani received his Ph.D. in analytical chemistry for the University of Florida. Prior to joining DSI, he served as Director CMC Strategy at Coherus BioSciences.
- Analytical Strategy
- Method Review
- Method Authoring
- Method Validation
- Design of Experiments
- CMO Selection
- Tech Transfer
- Small and Large Molecule
- Process Scale-up