Tausif Ahmed

Eighteen years of experience in the area of drug discovery, development and complex generics. Developing clinical and bioanalytical strategies for complex generics. Experience in preclinical, Modeling and Simulation, Biopharmaceutics, preclinical Toxocology, Conduct and design of Bioequivalence studies for complex generics. Experience in audit of BA-BE CROs as per USFDA, EMA, ANVISA, Malaysia and other Regulatory Agencies. Experience in conduct of generic Bioequivalence studies for Regulatory markets like US, EU and EMIN markets. Hands on experience in facing Audits for preclinical, Clinical and bioanalytical from different Regulatory Agencies. Experience in filing 505b2 applications and seeking scientific Advice from MHRA, USFDA, Bfarm, Netherlands and other EU Regulatory Agencies. Expert in PK-PD Modeling, IVIVC and Biopharmaceutics. Developing strategies for development of complex generics like liposomes, microsomes, nanoparticles, injectables, inhalation, topical, transdermal.