Increasing global exposure by overcoming challenges.

Regulatory Services

Bilcare GCS is concerned with providing assistance to our clients throughout the Clinical Trial Life Cycle. Our in-depth domain knowledge, coupled with exposure to regulatory practices and norms across the globe have made us a dependable ally when it comes to storage or distribution of CTMs. Bilcare GCS liasons services with central and state authorities for following:

  • Global Clinical Trials Phase II to IV.
  • BA/BE (Bioavailability and Bioequivalence) studies.
  • Controlled Drug substances approvals from Central Bureau of Narcotics and State authorities.
  • Drug Import & Export Licenses.
  • Site endorsement and transport permit for NDPS.
  • Shipping & Transportation Regulation.
  • QP Audit and Batch Release Services.

The regulatory services that are specific to Asia include:

  • Offers Expertise in Regulatory submissions through technical domain experts.
  • Review of Multiple documents generated before, during and after clinical trials.
  • Value additions in Study Protocols as per regulatory standards.
  • Experience in Harmonized data in terms of content and customized format – reducing review time and duplication.
  • Investigator's Brochure.
  • Clinical Trial Applications (Protocol, Ethics Committee, Amendments etc.).
  • Import and Export Permissions (Investigation and Comparator Drugs, Reagents etc).
  • Medical and Technical Writing – CTD summaries, overviews and expert reports.

Outside India, Bilcare GCS provides services through its credible Strategic Business Partners in countries such as Sri Lanka, China, Taiwan, S. Korea, Singapore and all Southern East Asian countries (Indonesia, Malaysia, Philippines, Thailand).