We have a track record of successful registration of many new drugs and substantial experience in operational excellence and quality management. We support our customers with preparing and proofing regulatory and quality documents always delivering on time with the highest quality. 

Regulatory Documents

Our expertise in this work area include:

  • Trial Protocols
  • Development Plans
  • Study Reports
  • Written Summaries
  • Narratives
  • Investigator's Brochures
  • Communication with Health Authorities, Ethics Committees, IRBs.
  • Scientific Publications
  • Translations from and into English/French    

Quality Documentation

Our expertise in this work area include:

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