Regulatory Planning & Consulting

Averion is experienced in guiding clients through the regulatory process, from regulatory strategy to client representation at Regulatory Authorities.

Regulatory strategic planning includes our knowledge of clinical endpoints, adaptive trial design, regulatory guidelines and development trends in key drug and device indications.

Our expertise includes functional knowledge and interaction with FDA, EMEA and national regulatory authorities around the globe.

Averion’s regulatory intelligence keeps current on regulatory guidelines specific to document handling procedures, electronic submissions, 21 CFR Part 11 compliance, and disease specific guidance.

Averion has successfully submitted orphan drug applications, INDs, NDAs and Subpart H components, MAAs, BLAs, MLAs, 510(k)s, and PMAs.

Regulatory Services include:

• Development and Review of Informed Consent Forms
• Collection of all Investigator Regulatory Documents
• Approval of Investigator Regulatory Packages for Release of Investigational Product
• Development and Review of Study Specific Guidelines
• Regulatory Submission Support:
  
  • IND amendments
  • IND safety reports
  • Annual reports
  • Safety listings, MedWatch and CIOMS