Regulatory Affairs

Our services in this area include

  • Registration Strategy in US, EU & Emerging Markets

  • Regulatory Feasibility Analysis

  • Strategies for product Filing and Variation

  • Advisory on CMC data generation for successful filing

  • Change Control Strategies

  • Subject Matter Expertise

  • Strategy for Query Responses

Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s behalf, regulatory due diligence etc form the heart of Regulatory Affairs. We at Cuckos have made a name for us, to run regulatory operations effectively and with top class quality for our clients.

  • Services include

  • Dossier Compilation for Emerging Markets/EU/US/Australia

  • Types – ECTD, ACTD, National Filing

  • PIL User Testing

  • Labelling Reviews as per National requirements

  • CPP Reviews

  • API Related

  • DMF Review

  • API filing with EDQM for obtaining CEP

  • Assessment/Review and filing of Amendments / Variations

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