Regulatory Affairs

Regulatory knowledge and expertise are an integral part of modern development and marketing strategies for medicinal products.

We have, therefore, established a competent regulatory team skilled in state-of-the-art project management and communication techniques.

The huge experience of our partners, along with your ideas combined with our know-how and service mentality guarantee a strong performance in:

Carrying out of the full registration process of a medicinal products in the Drug Registration Agency (DRA); obtaining of marketing authorization

Regulatory Affairs Service:

• Registration/renew of Food Supplement, Herbal products.
• Notification of food supplements and cosmetics in appropriate Agencies.
• Realization of some parts of the registration process.
• Prolongation of marketing authorizations.
• Preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of the DRA.
• User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission.
• Transfer of marketing authorization.
• Variations – submission and monitoring.
• Generation of expert reports on Quality, Non-Clinical and Clinical documentation.
• Pharmacovigilance service.
• Consultancy in Regulatory Affairs, collectiong information, consulting on completion of registration dossier, preliminary assessment of file, local language (or Baltic) pack development, registration procedure follow-up, corrections of PIL, SmPC, etc.
• Other.