Regulatory

Raland regulatory professionals can work with you to successfully navigate the ever-changing regulatory process.

  • Regulatory Strategy and Management
  • Preparation and Review of Regulatory Submissions
    • IND, CTA, eCTD, CTX, IDE, CTN, NDA, ANDA, MAA, BLA, PMA, and 510(k)
  • eCTD Vendor Audits
  • Review and Preparation of Drug Master File (DMF) and EDMF
  • Technical Files and Design Dossiers
  • Clinical Evaluation Reports (CER)
  • CMC Services and Document Submission
  • FDA 483/Warning Letter/Consent Decree response