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. Utilizing extensive experience and applying learning across projects, the team is able to effectively handle a wide variety of regulatory challenges and helps our 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 Indian drug control 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 dossier compilation, including CTD and eCTD format
• Regulatory approvals for
  - Phases I-IV clinical trials including new indications and   special population studies
  - Conducting BA/BE studies
• Export NOC for  biological samples for testing
• Approval of   Import license of drugs
• Safety reporting
• Product registration for marketing approval
• Strategies on global CTD and eCTD regulatory submissions   that conform to US FDA and ICH guidelines