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At Oceanic Pharmachem Pvt Ltd, regulatory services are managed by a dedicated team of professionals with extensive experience in the pharmaceutical industry. The team efficiently handles regulatory submissions and amendments, and liaises directly with regulatory authorities such as the USFDA, EU Member States, PMDA, KFDA, and others. With a proven track record in managing variations, responding to agency queries, addressing additional information requests, and coordinating pre-approval and renewal inspections, the team is well-equipped to support a wide range of regulatory filings, including NDAs, INDs, DMFs, ANDAs, MAAs, and more.
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