Drug Regulatory Affairs

 We are committed to our clients to provide our expert service for Drug Regulatory Affairs worldwide. We have a team of dedicated experts on Drug regulations who are basically responsible for your products registration, approval and International regulatory arenas through all phases of the drug-development process. We offer extensive industry experience shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for your product, from Bio analytical study requirements, pre-IND/pre-NDA meetings, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance.

We provide worldwide Regulatory Services including:

  1. Fast local regulatory approvals
  2. Regulatory with respect to IMPs Imports/Exports
  3. Expedited submissions of Regulatory dossiers
  4. Regulatory with respect to Bioequivalence & conduct clinical trials of new drugs
  5. Overall responsibility of Marketing Authorization

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