Regulatory Services

Expert Guidance for Seamless Regulatory Approvals. At Ardent Clinical Research Services (ACRS), our Regulatory Services are designed to streamline the approval process for clinical trials and product registrations, ensuring full compliance with national and international regulatory standards. With a deep understanding of Indian drug control regulations, CDSCO processes, and global regulatory expectations, we provide sponsors with efficient and reliable support across all regulatory milestones. Whether it's part of full study management or as a stand-alone service, our regulatory team ensures timely approvals and smooth navigation through the regulatory landscape.

โœ… Our Regulatory Expertise Includes:

๐Ÿ“„

Regulatory Dossier Compilation

  • Preparation and submission of comprehensive regulatory documents (Form 44, CT applications, etc.)
  • Compilation of clinical trial dossiers in accordance with CDSCO, ICH, and sponsor-specific requirements.
๐Ÿงช

Regulatory Approvals for Clinical Trials

  • End-to-end support for obtaining approvals for:
  • โ€ข Phase IIโ€“IV clinical trials
  • โ€ข Bioequivalence (BE) studies
  • โ€ข Medical device studies
  • Coordination with DCGI, CDSCO, and Institutional Ethics Committees (IECs).
๐ŸŒ

Import License Approvals

  • Preparation and submission of applications for import and use of investigational products in clinical trials.
  • Liaison with CDSCO Zonal Offices for timely clearance.
โš ๏ธ

Safety Reporting

  • Management and submission of SUSARs, SAEs, and Periodic Safety Update Reports (PSURs) as per regulatory timelines.
  • Compliance with ICH E2A, Schedule Y, and global pharmacovigilance standards.
๐Ÿท๏ธ

Product Registration for Marketing Authorization

  • Regulatory support for new drug applications (NDA) and post-trial marketing authorizations.
  • Guidance on documentation for formulations, generics, and imported drugs.
  • Coordination for label claims, stability data, and manufacturing site approvals.

๐ŸŽฏ Why Choose ACRS for Regulatory Services?

  • Deep domain expertise in Indian & international regulatory frameworks
  • Proven track record in expediting approvals
  • Customized regulatory support tailored to study scope and sponsor needs
  • Transparent communication and proactive liaison with authorities