Pharma Law Regulatory Albania

As part of the regulatory service, we prepare all the necessary documentation in order to obtain the Marketing Authorization for drugs, medical devices, food supplements and herbal products. We follow all administrative procedures actuated from the National Agency on behalf of the customer. We offer services that follow customer’s interests during registration, pharmacovigilance and yearly price declaration procedures Our studio guaranties full legal support for all problems or customers unclear questions about the pharmaceutical legislative aspect. We are able to support it’s needs even to the higher legal institutions. Being responsible for different issues as: - Control of dossiers in order to ensure compliance with the regulations set by Regulatory Agency and MoH - Submission of dossiers for registrations, renewals or variations - Obtaining Marketing Authorizations - Communication with institutions (Regulatory Agency, Ministry of Health, Food and Veterinary Agency) - Issues at Ministry of Health, like price declarations - Keeping up to date with changes in regulatory legislations and guidelines - Preparing Market Studies - Import and Export procedures