Regulatory Affairs

Regulatory submission is one of the most important milestones in the conduct of a clinical trial. Quality submissions are the key to expedited approvals, avoiding unnecessary delays.

We understand the Indian and global regulatory scenario really well. Our regulatory team is well experienced in preparation and submission of dossiers to the Indian regulatory and the site Ethics committees, assuring compliance with the Indian regulatory requirements as well as ICH-GCP.

Each submission is put together comprehensively and reviewed carefully; in order to make the first submission the most effective. Our team is experienced in liaising with the regulatory office to address any queries and to engage in communication to address regulatory queries.

As your partners, we can assist in obtaining regulatory authorization to carry out a clinical study as well as for import /export of clinical trial supplies and trial related samples.

Our Regulatory Affairs Service includes following:

  • Preparation of regulatory dossiers as per Indian regulatory guidelines, to obtain authorization to conduct clinical trials and import/export of study related supplies
  • Compilation of initial submissions, amendments, notifications, and closeout submissions
  • Collection, review and approval of site essential documents
  • Assessment and evaluation of regulatory Dossiers
  • Application for an Ethics Committee opinion
  • Assessment /review of Ethics committee approvals
  • Submission of regulatory dossier, subsequent query resolution and follow up
  • Obtaining import/export licenses for Investigational products and Clinical Trial Samples
  • Liaison and follow up with regulatory authorities
  • Trial related update submissions and approvals to ECs and applicable regulatory bodies
  • Regulatory Consultation
  • CE Marking for Medical Devices
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