Regulatory Support

Clinical Regulatory Affairs Services

There are a variety of submissions that may be required by regulatory agencies throughout the world. Utilizing strategies designed to address regulatory challenges and minimize additional questions, our team reviews, prepares and submits documents required for appropriate regulatory pathways. We can support a variety of regulatory activities including:

  • FDA US Agent for Foreign Establishments
  • Milestone FDA meetings (pre-IND, C, EOP 1/2, Pre-NDA/BLA and BPE)
  • FDA/EMA Advisory Committee and panel preparation
  • Health authority responses to questions
  • Resolution and response to safety issues
  • Representation with FDA and National Competent Authorities
  • FDA 505(b)(2) assessment and plans
  • Orphan, Pediatric, Fast-track, Breakthrough, Gain Act Designations
  • FDA and QMS Audits
  • Pre-submission support documents
  • New and Amended Drug Applications (NDA, ANDA)
  • Biologic License Applications (BLA)
  • Investigational New Drug Applications (INDs)
  • US FDA Quality System Regulation (FDA QSR) and ISO 13485
  • QMS compliance: ISO 13485, and 21 CFR part 820