Regulatory Affairs

AHC has been immensely successful in obtaining regulatory approvals for clinical development and commercial manufacturing of pharmaceutical, biologic and medical device products. We provide the most effective regulatory assessment and strategy for all stages of product development and life cycle management.

Our regulatory affairs expert keep vigilant track of the constant changes in the legislations surrounding clinical research inclusive of niche arenas like herbaceuticals, cosmeceuticals and nutraceuticals.

Our regulatory affairs professionals understand their critical role in the healthcare product life cycle. They provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.

* Regulatory Strategy and Consulting : Providing guidance on regulatory requirements and strategies for clinical trial development and approval processes.

* Clinical Trial Applications : Assisting with the preparation, compilation, and submission of regulatory documents required for obtaining clinical trial authorizations from regulatory authorities. Interfacing with regulatory agencies on behalf of the sponsor to address any regulatory queries or requests for additional information. Dossiers for SUGAM, MedDev

* Regulatory Compliance : Conducting regulatory compliance assessments to ensure adherence to applicable regulations, guidelines, and standards. Assisting with the development of Standard Operating Procedures (SOPs) and ensuring compliance with Good Clinical Practice (GCP) guidelines.

* Safety Reporting & Pharmacovigilance : Collecting, processing, and reporting adverse events and serious adverse events occurring during clinical trials. Assisting with pharmacovigilance activities, including safety data collection, analysis, and regulatory reporting. PSUR, DSUR preparation for CDSCO and EU regulatory. Assisting with post-marketing surveillance activities, including the preparation and submission of post-approval regulatory documents. Supporting regulatory submissions for product variations, labeling updates, or post-approval commitments.

We offer Regulatory Services not limited to…

  • CDSCO DCGI Approvals – SUGAM Online
  • CDSCO DCGI Approvals – MedDev Online
  • PSUR for CDSCO Submissions
  • PSUR for European Union Submissions
  • PSMF for European Union
  • QPPV for European Union
  • PMCF – Post Market Clinical Follow Up for Medical Devices
  • Drug Safety and Pharmacovigilance Support
  • Regulatory Compliance Strategy and Assistance
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