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Pharma Consultations

MEDICEPTION offers consultation to Pharma companies for their product registration and approvals. We support clients with clinical protocol design, its Review and conduct of the study. 

Our team members have expertise in clinical trial managements, as they inherit drug-discovery and development background of more than 20 years, and have successfully taken many IND candidates to Ph I-IV trials and finally into the market:

  • We work with regulatory agencies such as; CDSCO / DCGI & FSSAI to get approvals of new drugs, / or for its new indications, new formulations, Fixed Dose Combination (FDC). We also work for new food products, supplements, medical devices, diagnostics, being launched in Indian market.

  • We work in collaboration with CROs to provide cost-effective services and solutions. The major focus for exports in their formulation products are to be available at regulated and non-regulated markets around the globe, supported by strong research, regulatory and marketing teams.

Clinical trial approvals:

  • Regulatory permission to start clinical trials for PhI, IIa, IIb, III

  • CT waiver documents

  • BE and PK interaction studies for FDCs dosages forms and new formulations

  • Ethics committee approval 

Drug & Food product approvals:

  • Product approvals & NOCs - FSSAI

    • Complete registration package

    • Submitting & obtaining licenses

    • Approval from scientific committee

    • Formulation design advice

  • NCE & Generics drugs
  • Food & Neutraceuticals
  • Supplements
  • Diagnostic Kits
  • Vaccines
  • Cosmetics
  • Medical Devices
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