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SERVICES:
Regulatory


We offer a range of regulatory services and our philosophy is to work with you early in the development process in order to build a solid foundation leading to efficient global regulatory submission and approval.

Our services include:

  Agency meetings and negotiation (FDA, EMEA, EU and
     non-EU Competent Authorities)
  Obtaining Orphan Drug Designation
  Development of Paediatric Investigation Plans
  Clinical Trial Approval (CTA)
  Preparation of IMPDs
  IND preparation
  Preparation of CTD modules 1.8.1 (Detailed Description of the
     Pharmacovigilance System) and 1.8.2 (Risk Management Plan)
  Preparation of the Clinical Overview and Clinical Summary
  Regulatory Document Management
  Building the eCTD submission and regulatory publishing






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