Science Driven CRO

Science Driven CRO

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Regulatory Affairs

REGULATORY AFFAIRS

Regulatory affairs provide strategic, tactical and operational direction to ensure compliance with applicable regulations to expedite the development and delivery of safe and effective products.

By optimally planning and implementing appropriate and tailored regulatory strategies for your clinical development plan, Europital can lead you through successful interactions with authorities and accelerate your product towards approval.

  • Strategic Consulting
  • Development plans
  • Dossier Submission
  • Integrated analysis plans
  • Dictionary coding and recoding for consistency
  • ISS and ISE creation
  • Regulatory Document Writing, including: Dossier Content, Annual Reports, IMPDs
  • eCTD preparation, publishing and submitting through electronic portals
  • NDA, BLA, MAA writing, compilation and submission
  • Preparation, Management, and Submission of Regulatory Dossiers (INDs, CTAs, MAA, BLAs, and NDAs)
  • Strategic guidance and support for FDA and EMA meetings
  • Gap Analysis of Regulatory Data
  • Drug Development Plans
  • Pediatric Development Plans
  • Regulatory Filing Strategies and Designation Requests, such as Orphan, Fast-Track and Breakthrough
  • Facilitate and attend agency and scientific Advice Meetings
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