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.