We are specialized in extending our following services for API and Intermediate drugs, 

● Complete Process validation from R and D Scale to plant scale.

● Investigation and compliances with CAPA proposal.

● Deviation management, Change control management ,QMS system establishing.

● Regulatory Audit’s response drafting.  

● Manufacturing assurance in terms of BPR , SOP, and STP execution.

● Data integrity and plant personnel trainings.

● Technical writing and finalisation of various documents in cGMP purview.

● Qualification of the equipments, various ancillaries in green field project.

● Quality oversights for end to end outsourcing activities.

● CSV, 21CFR Part 11, GAMP5 Compliances.

Mr. Ravi Chinchalkar

18 Years of Diverse experience in the field of API Quality Assurance, Process Validations, failure Investigations.

●    Worked with major Indian Pharma. Companies: Lupin, Orchid and Dr Reddy’s Ltd.

●    Over 50 API New Products validation after scale up from R & D scale (development life cycle).

●    Hosting for various customer audits, review of proposed remedial CAPAs for compliance.

●    Remarkable work in investigations and compliance of the WL sites.

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