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Regulatory Affairs

Regulatory-Affairs

At Mudra Clinical Research Organization (CRO), we offer expert consultation to our clients on various aspects, including:

  • Methodology for approaching regulatory bodies, ensuring effective strategies for approvals.
  • Preparation and submission of regulatory dossiers and product registration applications for faster approvals.
  • Time management techniques to expedite regulatory processes and achieve quicker regulatory approvals.
Our dedicated in-house regulatory team possesses extensive knowledge of the Indian regulatory scenario, enabling us to provide the best assistance in resolving queries raised by the “Drug Controller General of India” (DCGI) and ensuring swift follow-up submissions.

Services We Provide:

  • Conducting an initial assessment of your data to optimize the chances of rapid clinical trial approval.
  • Preparation of regulatory dossiers and efficient regulatory strategy planning for faster approval timelines.
  • Filing and tracking of submissions, as well as addressing any queries raised during the review process.
  • Managing post-approval regulatory submissions and amendments.
  • Submission of the final study reports to regulatory authorities.
  • Preparation and submission of product registration applications for import, manufacture, and marketing in India.
  • Complete Import & Export License Management for clinical supplies and biological products and samples.
  • Staying up-to-date with all national legislation related to clinical trials to ensure full compliance with applicable regulations.

IRB/IEC Submissions:

Mudra CRO is well-versed with Ethics Committee requirements, enabling us to ensure a fast turnaround time for protocol submissions. Our deep familiarity with local requirements and practices helps avoid unnecessary delays in study commencement. With our vast experience in obtaining IRB/IEC approvals, Mudra CRO professionals bring valuable expertise to your clinical development programs.