Global Regulatory Affairs

Global Regulatory Affairs

Accelerate Approvals with Strategic Regulatory Leadership and Execution

We understand drug development from beginning to end and take a holistic approach to guiding your program forward by providing these core regulatory affairs capabilities:

Strategy: Global Regulatory Affairs provides the overall strategy, oversight, coordination and reach for global clinical development

Publishing: Dedicated Regulatory Publishing experts compile, electronically publish and submit any Regulatory document required, in accordance with local regulations

Relationships: Global Regulatory Affairs and Subject Matter Experts manage Agency guidance and scientific advice meetings to facilitate actionable project progress leading to approvable submissions

Review and Planning: Global Subject Matter Experts provide experienced and nuanced review and strategic advice on pre-clinical, pharmacology, and CMC elements of your program

Intelligence: Global Regulatory Intelligence staff access up-to-the-minute Regulatory Guidances to generate harmonized global regulatory considerations

Medical Writing: Degreed professionals prepare expert protocols and clinical study reports, and conduct thorough literature reviews and document preparation

End-to-End Regulatory Program and Lifecycle Management

Drive the development of your products – from preclinical proof-of-concept candidates to approved products primed for post-marketing label extension and regulatory maintenance – using up-to-the-minute guidance from Medpace experts. Medpace’s integrated team helps plan and coordinate each aspect of regulatory strategy and engagement, balancing strategy, data, analysis, and timelines by globally optimizing regulatory interactions and strategic approaches.

Here’s How We Can Help:

  • Targeted program review, including pre-clinical, pharmacology, CMC, and clinical elements
  • Global Regulatory Considerations assessments and Clinical Development Plan input
  • Target Product Profile development
  • Global Regulatory and Scientific Advice strategies
  • Global Regulatory Agency and Scientific Advice meeting strategy, preparation, and executions at all stages of development
  • Full program Global Regulatory guidance and support
    • Creation and implementation of a strategic integrated product development plan, including pre-clinical, pharmacology, CMC, and clinical elements
    • Regulatory management through full product life cycle
    • Regulatory strategy and agency communication to obtain first-cycle approvals
    • Submission technical writing
    • Regulatory eCTD dossier preparation, publishing and submission