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Regulatory

We have a dedicated team of qualified and experienced pharmacists to carry out all the regulatory work required for the registration our products internationally. We have more than 150 dossiers ready in CTD or ACTD or Regional formats. We have 100+ products are under registration in more than 20 countries across the globe.

Our regulatory team is responsible for the following tasks:

  • Dossier preparation as per ACTD, CTD or country specific guidelines.
  • Obtaining CPPs, FSCs and other supporting documents along with necessary apostle, legalizations and/or notarization.
  • Planning and submitting product samples to respective MoH or their affiliated laboratories for testing and registration purposes along with Working standards (& impurities if necessary).
  • Timely submission of product related queries raised by respective MoH/FDA throughout the product registration life cycle.
  • Submission of Third-party laboratory reports of registration samples or commercial shipment samples if required by respective FDA/MoH.
  • Assisting our QA, QC and F&D departments in obtaining innovator samples for conducting CDPs and coordinating with CROs for conducting BE studies for specific drugs.
  • Obtaining the samples under test license for testing and development of data if any product/s not available in India
  • Submission of PSUR and RMP data for any product/s required by respective MoH/FDA