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Global Regulatory Experience and Insight to Fit Your Specific Needs

SynteractHCR’s global team of experienced regulatory affairs professionals are prepared to guide your drug development strategy through the entire life cycle of your product. With capabilities to support North and South America, Europe and Asia Pacific, we support you with up-to-date global know-how coupled with local experience to manage complex, ever-evolving regulatory environments and requirements. The distinctive knowledge of our seasoned team members is matched to your specific project needs, to ensure the most comprehensive regulatory strategy.

Our global regulatory services include:

Strategic Consulting

  • Drug Development Plans
  • Pediatric Development Plans
  • Regulatory Filing Strategies including Special Pathways
  • Gap Analysis of Regulatory Data
  • Facilitate / Attend Agency and Scientific Advice Meetings

Regulatory Document Writing

  • Application/Dossier Content (Investigational and Marketing)
    • CMC/Quality, Nonclinical and Clinical Sections
    • Annual Reports
    • IMPDs
  • Meeting Requests and Packages
  • Designation Requests (Orphan, Fast-Track, Breakthrough, etc.)
  • Development Plans

Preparation, Management and Submission of Regulatory Dossiers/Applications (INDs, CTAs, MAA, BLAs and NDAs)

Local Representation - Legal/Authorized Representation

Electronic Compilation and Publishing (eCTD)

Experience

  • New chemical or molecular entities (NCE/NMEs), Biologics, Devices and Drug/Device Combination Experience
  • Investigational and Marketing Applications

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Brexit and the EU Clinical Trials Regulation

Contact SynteractHCR

  • USA: +1 760 268 8200
  • Europe: +49 89 12 66 80 0
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