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.