Bharat Patel
Head-Analytical R&D at Hetero Group of company ( Injectables)
- Role
- Head-analytical R & d at Hetero Group at Hetero
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Bharat Patel
Strategic Pharma professional offering more than 23 years’ experience with impressive success in Research in Analytical Method Development, Method Validation and Technology Transfer across generic injectable formulation such as Liquid Parenteral, Emulsion, Lyophilized, Peptide molecule based formulation and Liposomal Dosage Form for USA, EU, Brazil and ROW Market. Faced various regulatory audits such as USFDA, MHRA (UK), TGA (Australia), ANVISA (Brazil) and INVIMA (Colombia). Leading an analytical Characterization activity as per regulatory guideline (USFDA) for Peptide molecule based formulation. Having exposure of complex injectable products. Involved in strategies for Technical transfer of Analytical Methods from R&D to manufacturing facility and Batch testing site (BTS) in Europe and Canada Well versed of any laboratory deviations/Incidents and their CAPA related to Analytical Method Validation & Transfer. Well versed of the studies like extractable and leachable, drug excipient compatibility study, forced degradation study, hold time study and diluents compatibility Study etc. Ensured compliance in all Analytical activities are maintained as per SOP. Having exposures of more than 80 products development for US/EU/ROW market. Support to Regulatory team for ANDA filing as per schedule/timelines. Support for operational budgets, cost / expenses controls and resource planning to meet corporate strategic objectives. Provided strategic & scientific guidance for the analytical development of Injectable Formulations and drove analytical research at various levels. Expertise in setting up entire analytical laboratory and advanced analytical instruments.
Experience
Head-analytical R & d at Hetero Group
Aug 2018 — Present · Hyderabad, IN
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