Serviss

We can provide such services in Lithuania, Latvia, Belarus, Russia:

1. Pharmaceutical marketing (food supplements and medicinal products).

2. Regulatory Affairs Service:

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

– 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.

– Generation of expert reports on clinical trial and pharmacoeconomics, applying for reimbursement in Lithuania.

– 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.

3. Legal consultation on pharmaceutical issues.