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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 forĀ  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

 

 

 

 
     
Phase I-IV Clincal Trials
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