Keyur Patel

WORK HISTORY

EDUCATION

SKILLS

ABOUT KEYUR PATEL

Over 23 years of experience in Formulation Development Department in various reputed Pharmaceutical companies. • Expert in formulation development, scale up and technology transfer in accordance with USFDA, European, TGA, SUPAC and ICH guidelines. Well experienced in developing and submitting complex generic solid oral dosage forms Filed several NCE-1 and first to file projects • Designed and developed enteric coated and polymer matrix based modified release solid oral dosage form. • designed products using Hot melt extrusion technology and developed product using foam hot melt extrusion technology • Hands on experience about Transdermal drug delivery systems. • Well acquainted with use of IVIVC using Gastroplus model in development of formulation development. • Hands on experience on Formulation Development of various Pharmaceutical Dosage Forms like Tablets, Capsules, Semisolid formulations, Transdermal and Novel and controlled release formulations etc. Developed innovative formulations within timeline and applied patent for that. • Well acquainted with formulation development for Abbreviated New Drug Application (ANDA) using Quality by design (QBD). Developed product development reports using Question based review (QBR) and Quality Overall Summary (QOS). • Strong at technology transfer from pilot plant level to manufacturing floor. • Excellent documentation, analytical, project management and inter-personal skills. • Well organized independent who likes to work as a team. • Excellent command over MS-office – Word, PowerPoint, excel, internet. • Admirable understanding of Statistical methods in experimental design and evaluation.