Your Trusted Partner For Clinical Research and Pharmacovigilance

Regulatory Affairs

At CLINEXEL, we provide Clinico-regulatory services including CT dossier preparation & CA approvals, pre-IND dossier preparation & coordination for pre-IND/ scientific advice meetings, IND filing including CC with the Agency.

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CLINEXEL SERVICES

  • Regulatory Consulting and Strategic Services
  • Preparation of Clinical Development Plan
  • Preparation of pre-IND Meeting Dossier,
  • Facilitating Pre-IND and Scientific advisory meetings
  • Filing Clinical Trial Applications
  • Supplemental NDA / Subsequent IND for Life Cycle Management (new formulations/ indications)
  • Regulatory Compliance and Gap Analysis of IND dossiers for IND filing
  • Package Inserts (PI) -new PI development, Maintenance and Updates
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CLINEXEL EXPERTISE

  • Strong Knowledge of Regulations- India, USFDA, EU, ROW
  • Pre-IND, scientific advice & End of Phase meetings
  • Industry Experience of Clinical Development, Regulatory Meetings, Label Management & Variations
  • Expertise of Hybrid Applications & 505b (2)