We have a dedicated team of qualified and experienced pharmacists to carry out all the regulatory work required for the registration of our products internationally. We have more than 250 dossiers ready in CTD or ACTD formats. We have 190+ products registered in more than 37 countries across the globe.
Our regulatory team is responsible for the following tasks:
Dossier preparation as per ACTD, CTD or country specific guidelines.
Obtaining COPPs, FSCs and other supporting documents along with necessary legalizations and/or notarization.
Planning and submitting product samples to respective international labs for testing and registration purposes.
Timely submission of product related queries raised by respective ministry of health throughout the product registration life cycle.
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.