Suhas Patel Email & Phone Number

• More than 11 years’ of experience in pharmaceutical industry as a formulation scientist for the generic development of Oral Liquid ( solution, suspension, powder for suspension, powder for solution), nasal spray formulations , Sterile formulation like ophthalmic emulsion, Otic Suspension, Inhalation Suspension , Semisolid dosage formulation like ointment, gel, cream. • Well Experienced in designing, conducting and supervising formulation development, process optimization and scale up of novel and generic drug products (Semisolids, liquid, Nasal & Sterile dosage forms).• Worked on ANDA, 505b2, Paragraph IV and PAS submission.• Experience in writing eCTD compliant CMC documents (Product development report, QOS and other formulation related documents) for FDA submission.• Involved in troubleshooting investigations, deviations, CAPA’s and FDA deficiency letters in a timely manner.• Excellent understanding and practical experience of FDA, USP, ICH, SUPAC, cGMP regulatory guidelines.• Oversight management of manufacturing activities at CMO partners to ensure quality and timely deliverables.• Well proven Collaboration with Analytical, Purchase, Regulatory, Operation and other departments for Project Management activities.Key Skills:Pre formulation • Formulation and process development • Scale Up and technology transfer • DoE • QbD • Physicochemical characterization • Regulatory compliant CMC documentation • FDA/ICH Guidelines • Team management • Microsoft office suite.

Listed skills include Pharmaceutical Industry, Gmp, Pharmaceutics, Formulation, and 2 others.