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.
Following are the regulatory services which Oceanic Pharmachem Pvt Ltd also provides:
- Pre-Registration Services
- Registration Services
- Post-Marketing Services
- Specialty Services – Technical
- Specialty Services – Operational