Regulatory Authority and Ethics Committee submissions

  • Preparation of complete packages for the Regulatory Authorities and Ethics Committees
  • Advice to Sponsor on specific local requirements for submission documents
  • SanaClis expertize of study documents provided by Sponsor/other parties involved
  • Translation of documents according to local requirements
  • Application to the national Regulatory Authority and Ethics Committees
  • Submission to RA & ECs and advise on review timelines / meeting dates
  • Updates of requirements
  • Clarification of requirements – interface between sponsor and RA/EC (local)
  • Obtaining and check / translation of approvals

Regular contacts with RA/EC throughout the study

  • Compliance with international and local reporting requirements
  • Follow-up submissions
  • Notifications

Import/Export licenses/permits
Certifications by local bodies (if applicable)

SanaClis regulatory specialists attend regularly advisory sessions and seminars organized by RA and RA experts to be up-to-date in changing regulatory environment.