ChemDiv chemistry of cures

Regulatory management is responsible for the review and compilation of regulatory documents provided by the sponsor and/or ChemDiv.

Our regulatory managers:

• Review and submit Study Subject Insurance and Investigator Indemnity per local regulations
• Prepare the Clinical Trial Dossier for submission to Ethic Committees and Regulatory Authorities
• Submit the regulatory dossier and closely track all steps of document processing
• Obtain initial Regulatory Approval in the minimal possible time — 10-12 weeks after submission of trial documents
• Obtain Import/Export licenses for study drug and non-drug supplies
• Submit all study specific documents to Ethics Committee and / or Regulatory Authorities (per local regulations and GCP requirements) during the study

Find attached:

ChemDiv-Clinical_Development.pdf