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Regulatory Services
  • A team of professionals, with significant experience within the pharmaceutical sector, manages regulatory services at Oceanic Pharmachem Pvt Ltd. The team takes care of managing regulatory submissions & amendments; communications with Regulatory Agencies (USFDA, EU MS, PMDA, KFDA etc.) with a strong track record of dealing with variations, additional requests, enquiries, onsite pre-approval inspections and renewal inspections by respective agencies, the team is also able to smoothly handle NDAs, INDs, DMFs, ANDAs, MAAs and other regulatory submissions.