Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts

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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.

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