Regulatory Services

Clinigene provides regulatory services to facilitate all stages (Phases 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. To date, we have achieved a 100% success rate of regulatory approvals. Our experience in handling a wide variety of regulatory challenges helps sponsors meet exigent timelines. Our ability to assist sponsors obtain regulatory approvals is supported by a deep understanding of, and experience in dealing with the complexities of the Indian regulations. We have the ability to provide services as a complete study management and/or as customized services.

Expertise

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

Services

• Regulatory approvals for Phases 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 US FDA and ICH guidelines