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More info about SanaClis

Regulatory Services

SanaClis

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.

Quick Contact Regulatory Services