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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. 

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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:

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  • 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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