Modern medicine and pharmaceuticals – a delicate balance of science, technology, humanity and ethics!
The team of Toncheva and Partners Law firm has in-depth knowledge and many years of practical experience in the field of medical and pharmacy law.
Our lawyers defend with equal determination and in the name of justice, both the violated rights of patient and the rights of medical professionals in the field of health care.
We provide comprehensive legal services to medical institutions for hospital and other than hospital services in the field of medical law.
We are your constant partner in your activity as a doctor or medical specialist for protection of your rights, both in your relations with medical institutions and in your relations with patients.
We advise on all issues related to the marketing and authorization of medical products, nutritional supplements and cosmetic products’ usage, as well as their distribution and approval on the Bulgarian and international markets.
The firm’s practice is oriented towards providing legal assistance in the following areas of medical and pharmacy law:
- Registration and comprehensive legal service of medical facilities for hospital and other than hospital care;
- Preparation of the internal acts regulating the activity of the medical facility;
- Registration and comprehensive legal service of Tissue Banks, representation before the Ministry of Health and Transplantation Agency;
- Registration and comprehensive legal service of In vitro centers;
- Legal service for companies in Pharmacovigilance and Cosmetovigilance;
- Legal assistance during an inspection by the Regional Health Insurance Fund /RHIF/, EA Medical Audit /EAMA/, Regional Health Inspection /RHI/ etc.;
- Legal consultations and legal representation of medical institutions, doctors and patients in “medical malpractice” cases;
- Legal consultations for production, import, export and trade in the market of medicine and cosmetic products and related permitting and notification administrative regimes;
- Clinical trials;
- Legal services to wholesalers and pharmacy chains;
- Consulting on any regulatory and corporate matters, pricing and reimbursement, regulatory compliance, manufacturing, marketing, promotion, advertising and distribution, protection of intellectual property rights, antitrust and competition matters, employment matters;
- Representation before local regulatory authorities – the National Council on Prices and Reimbursement of Medicinal Products, the Transparency Commission, the National Health Insurance Fund, the Executive Agency for Medicines, etc., in connection with the approval of prices, reimbursement, matters related to advertising and donations;
- Procedural representation in procedures for appealing acts of regulatory bodies, in proceedings before the Commission on Protection of Competition (CPC) regarding unfair competition, abuse of a monopoly position, as well as in competition advocacy procedures;
- Advising healthcare investors at all stages of the project – from lease/purchase of properties to planning, construction, regulation, public-private partnerships, public procurement, labor issues, commercial agreements, personal data and right to privacy protection.
EXPERTISE
CUSTOMERS FOR US
“For me, for my partners and colleagues, one thing always remains true about AD “Toncheva and Partners” – the feeling of security, peace of mind, that we are in the right place and will receive the right advice.”
National Board of Tourism
Dr. Polina Karastoyanova, CEO
“Toncheva and Partners JSC has the necessary expertise covering all needs.”
Association AIBEST
Nora Ishkova, CEO
“I was impressed by the depth of the legal research and the comparative analysis they did between the Bulgarian legislation and the European framework for early childhood education and care.”
Foundation for children at risk around the world
Rositsa Bogalinska-Petrova, CEO