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.
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.