Full Clinical Trial Life Cycle Service (Preparation, Application, Post-Approval Maintenance, and CSR Submission)
- Developing regulatory plans i.e. clinical trials authorization processes for submissions to competent authorities and ethics committees (Phase I to Phase IV) and/or observational studies of FDCs, Biosimilars, AYUSH products, medical devices, or nutrition products.
- Preparation and review of regulatory documents e.g., study protocol, IMPD, IB, IMP labels, ICF, import/export licenses etc.
- Supporting compliance assurance efforts as per local or international guidelines and standards.
- Providing end-to-end support for various submissions including protocol/ IB amendments, change of site/principal investigator, and registration.
