Registration Dossiers

drugs-1474526

We draft and prepare the necessary Registration dossiers to comply with international standards. In particular,
we focus on providing our customers with the documentation necessary to obtain GMP certifications.
We help with drafting the Marketing Authorization Application for registration in the European Union and with
the necessary documentation for obtaining the Certificate of Pharmaceutical Products within the European
Union.

We ensure full technical support for production of Pilot/Validation Batches and performance of stability studies,
by providing

  • Drafting of the necessary Documentation;
  • Personnel support with physical presence during the production phase.
  • GMP documentation

We are able to provide our customers with:

  • Batch Records
  • Standard Operating Procedures (SOPs)s for relevant processes:
  • Validation procedures including media fills;
  • Qualification procedures of machinery and main services: WFI, PW, HVAC, autoclaves, tunnels and fillingmachines;
  • Cleaning Validation procedures.