The pharmaceutical industry and the medical device and food supplement markets rank among the most dynamic and challenging sectors globally. These industries demand an in-depth understanding of regulatory frameworks and a tailored approach to addressing their unique legal and economic challenges.
Our law firm provides a comprehensive suite of legal services tailored to the needs of the pharmaceutical, medical device, and food supplement industries. With our proven expertise and commitment to staying ahead of regulatory changes, we help clients overcome industry challenges and seize growth opportunities with confidence.
We offer comprehensive assistance in dealing with institutions such as the Bulgarian Food Safety Agency and the Bulgarian Drug Agency, ensuring compliance and facilitating smooth operations for our clients.
Our Services Include:
- Obtaining Wholesale Trade Permits
Support in acquiring permits for wholesale trade in medical devices or pharmaceuticals, ensuring compliance with regulatory requirements. - Applications for Food Supplements and Special Medical Foods
Assistance with applications for the sale of food supplements and foods designed for special medical purposes. - Trade Notifications for Medical Devices
Preparation and submission of required notifications for the trade of medical devices. - Regulatory Advice
Guidance on the manufacture, import, export, labelling, and distribution of pharmaceuticals, medical devices, and food supplements to ensure full compliance with Bulgarian and EU regulations. - Regulatory Compliance Services
Comprehensive legal services to facilitate lawful manufacture, storage, and distribution of pharmaceutical products, medical devices, and food supplements. - Contractual Assistance
Legal support in drafting and negotiating key contracts, including:- Manufacturing and supply agreements
- Distribution contracts
- Warehousing and logistics agreements
- Permit Applications
Assistance in obtaining all necessary permits for the import, export, and distribution of pharmaceutical products, medical devices, and food supplements. - Intellectual Property Services
Expert advice and representation on all intellectual property issues, including industrial design and trademark matters, that may arise in the course of trade in these sectors.
Our tax department provides advice on double tax treaties, VAT and corporate tax, as well as representation before the National Revenue Agency and the competent courts in cases of litigation.
Thanks to our participation in Globalaw, our clients can rely on our contacts with law firms in Central and Eastern Europe as well as in more than 80 countries worldwide.