Regulatory Services

Regulatory Services

We have a dedicated team that focuses on the regulatory requirements that must be satisfied before clinical research may begin.We collaborate with our sponsors to assist them with complex regulatory issues, pathways, regular tracking of the application status, and changing requirements to ensure study-related approvals are in place in a timely manner, in coordination with the project management team, and to stay ahead of timelines.

  • Activities relating to the study are carried out by adequately trained employees. Before allocating any study-related responsibility, seniors ensure training.
  • All study-related documents are supplied as soon as feasible in the trial master files, and all key details are included.
  • Continuous system and document verification guarantees that the facility is ready.
  • An in-house quality monitoring team examines processes and records throughout the trial to guarantee compliance with study protocol standards.
  • On a regular basis, the in-house quality assurance team performs system, facility, and equipment audits to guarantee compliance with internal procedures, as well as study audits to assure compliance with research protocols.
  • Senior management is always reviewing the quality systems of various departments to ensure that all standard processes and practises are followed.


How are applications for Clinical Studies carried out?

Clinical study applications are submitted online using the SUGAM Portal, an e-Governance solution for CDSCO created by the Central Drugs Standard Control Organisation (CDSCO).

How can I submit a form to any CDSCO division?

Follow the procedures below to submit a form to any of CDSCO’s divisions.

How can I check the progress of my application?

You may check the progress of your applications online. View the status of submitted applications by checking the ‘Status’ column on the displayed webpage. (CDSCO establishes timelines for the aforementioned applications.)

Important Regulatory for Study in WORLD

  • Central Drugs Standard Control Organization (CDSCO)
  • US Food and Drug Administration (FDA)
  • Therapeutic Products Directorate (Health Canada)
  • European Medicines Agency (EMA)
  • Therapeutic Goods Administration (TGA)
  • World Health Organization (WHO)


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