In order to obtain marketing authorizations for medicinal products for human and veterinary use in countries belonging to the European Union and the post-marketing regulatory management, it is necessary to implement specific regulations and guidelines that apply at a European level.
However, special requirements and procedures may differ between the various Member States. In non-EU countries the legislation relating to medicinal products for human and veterinary use and the procedures for placing them on the market can vary substantially.
DR International is able to assist companies involved in all stages of the marketing authorization of medicinal products for human and veterinary use, thanks to an extensive network of expert regulators in European countries and in certain countries outside the EU, the knowledge of which is essential to appropriately manage all the activities to be conducted in individual states.
Among the services that DR International is able to offer, are:
- Regulatory Intelligence
- Pharmacovigilance Outsourcing
- Scientific Information
- Due diligence