As you take your products to international markets, we support you in dossier preparation, submission and follow-up in line with the legislation of the target country.
- Support and guidance in preparing marketing authorisation dossiers in line with target-country legislation
- Coordination with distributors; follow-up and reporting of authorisation procedures in each country
- Meetings with local representatives and authorities in the EU, CIS, Gulf and MENA regions
- Preparation of variation applications abroad
- Preparation of application dossiers for GMP inspections abroad
- Conversion of dossiers to eCTD and ACTD formats
- CPP and free sale certificate applications
