Regulatory

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.