• We have a track record of successful registration of many new drugs and substantial experience in quality management
  • We support our customers with preparing and proofing regulatory and quality documents
  • We offer fixed-price, deliverable-based services
  • We guarantee high quality and strict compliance with timelines to all our clients

   

Regulatory Documents 

Quality Documentation

   
    
  • Pre-clinical protocol
  • Clinical protocol
  • Protocol amendment and amendment summary
  • Clinical Study Report Phase I or IV (figures, graphs and appendices provided)
  • Clinical Study Report Phase II or III (figures, graphs and appendices provided)
  • Safety narratives
  • Investigator's brochure (initial)
  • Investigator's brochure update
  • Clinical Summary
  • Clinical Overview
  • Scientific Publications
  • Translation from and into English 


  • Policies
  • Standards
  • SOPs
  • Work Instructions
  • Training Material