Regulatory Services

See details of our regulatory services here.

Regulatory authority and ethics committee submissions

• Preparation of complete packages for the regulatory authorities and ethics committees
• Advice to sponsor on local requirements for submission documents
• SanaClis expertise of study documents provided by sponsor and/or any third parties involved
• Translation of documents by certified staff/agency
• Applications to the national regulatory authorities and ethics committees
• Submission to RA & ECs/advise on review timelines/meeting dates
• Updates of requirements
• Clarification of requirements – interface between sponsor and RA/EC
• Obtaining and check/translations of approvals and other RA / EC Documents
• Regular contacts with RA/EC throughout the study
• Compliance with international and local reporting requirements
• Follow-up submissions
• Notifications
• Import/export licenses and permits (if applicable)
• Certifications by local bodies (if applicable)

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