Regulatory Services

Clinigene provides regulatory services to facilitate all stages (Phase I-IV) of drug development. We accomplish this by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards regulatory authorizations. Till date, we have received 100% success rate of regulatory approvals. Our experience in handling a wide variety of regulatory challenges helps sponsors in meeting exigent timelines. Our ability to assist sponsors in obtaining regulatory approvals is supported by a deep understanding of and experience in dealing with the complexities of Indian regulations. We are capable of providing services as complete study management and as customized services.

Expertise

- New chemical entities
- New biological entities
- Generics / Biosimilars (rDNA products)
- Monoclonal antibodies
- Stem cells
- Medical devices

Services

• Regulatory approvals for Phase I-IV clinical trials including new indications and special population studies
• Regulatory approvals for conducting BA/BE studies
• NOC for export of biological samples for testing
• Approval of Import license of drugs
• Safety reporting
• Product registration for marketing approval
• Regulatory dossier compilation, including CTD and eCTD format
• Strategies on global CTD and eCTD regulatory submissions that conform to FDA and ICH guidelines