Services:

Regulatory Affairs

Broad Regulatory Affairs Knowledge Internationally

Services:

Regulatory Affairs

Taking new products successfully through clinical development, submission, and approval can be a difficult, expensive and lengthy process. Whether your new product is a drug, biologic, device, or even a combination of them, we understand the nuances of regulatory requirements and have the resources and proven expertise to address your specific needs, in whichever country you are applying. 

Our experts can help guide you throughout the full continuum of clinical development, whether it is preparing the IND or IDE, providing regulatory services throughout each study, or preparing the NDA, BLA, MAA, or PMA. 

With capabilities to support North and South America, Europe, and Asia Pacific, we provide you with up-to-date global know-how coupled with local experience to manage complex, ever-evolving environments and requirements. Our experts also are authorities in the new European Clinical Trial Regulation currently being implemented.

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)
    • ïCMC/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
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