FormaliS conducts audits of production sites to check compliance with regulations and study plans, as well as to assess the reliability and quality of the data.


  • Auditing according to cGMP, Annex 13 to GMP or ISO standards
  • Feasibility audits
  • Site audits
  • System audits
  • Report audits


  • Production, packaging and distribution of clinical study batches
  • Specific assignments


  • current Good Manufacturing Practice (cGMP)
  • Annex 13 to GMP
  • Local Regulations
  • Biosafety Guidelines for Biotech
  • HACCP for Food Processing