Pharmaceutical professional with 11 years Research experience in Formulation & Development of Generic Solid Oral Dosage like Immediate Release , Modified Release, Delayed Release, MUPS formulation for Regulated market USA, Europe, WHO etc Experience of Prototype product development, Scale-up, Exhibit batches and Technology transfer.# Sound knowledge of handling projects from scratch to successful exhibit batch.# Sound knowledge of issuance of licenses required to initiate product, import reference product, conduct bio equivalence study and exhibit batches at GMP facility.# Preparation & Review of various documents like Manufacturing Formula Record, Finished Product Specification, SU protocil, Hold time study protocol etc.# Expertise in preparation of QbD based Product Development Report (PDR) as per regulatory requirement.# Handling regulatory queries and prepare response. Specialties: Expertise in Oral Solid Dosage, Top-Spray Granulation, Bottom-Spray Coating, Tablet coating.