Dr. Jignesh Shah
(B.Pharm., M. Pharm., Ph.D)
Professor, Head of Department regulatory Affairs
Area of Interest
Pharmaceutical Regulatory affairs – dossier requirements (CTD, eCTD,), DMF, ASMF, SMF requirements, annual product quality review, Validation Documents Evaluation, PSUR, Dossier Module 4 and Module 5, BA/BE document requirements, PK endpoint study document requirements, NDA, ANDA, IND requirements.
Method Development, Analytical Method Validation , Dissolution AMV, Stability indicating studies, GMP Documentation and GLP.
Analytical Method Development using modern instruments like UV Spectrophotometer, HPLC, FTIR etc.