CERTIFICATION/LICENSING

License for import of drugs:

  • Audit of documents and kinds of activities;
  • Assistance/preparing the “ dossier of importer”;
  • Preparing a set of documents for receiving a license for import;
  • Consult and legal support of “agreement” process;
  • Receiving a license for import of drugs.

GMP Certification:

  • Preparing a set of documents for Application submission for GMP compliance certification;
  • Harmonization of inspection conditions;
  • Harmonization of inspection report;
  • Receiving of GMP Certificate.

Confirmation of compliance requirements GMP:

  • Preparing a set of documents for receiving a GMP confirmation;
  • Coordination of expertise steps (for non-residents PIC/S who have GMP from PIC/S countries);
  • Receiving a GMP conclusion confirmation.