Life Sciences (Pharmaceutical and Medical Device Law)

Our life sciences practice group consists of experienced attorneys with international background, subject-matter expertise, and industry awareness. We are fascinated by the new achievements in the drug and medical device industry and strive to help our clients succeed. Our clients are leading pharmaceutical, and medical device manufacturers, distributors, biotechnology companies, pharmacies, trade associations, and research institutions.

Particularly, we advise on a broad range of compliance and regulatory issues, including:
  • Market authorizations
  • Clinical trials and non-interventional studies
  • Good clinical practice (GCP) and good manufacturing practice (GMP)
  • Labelling of medicinal products and medical devices
  • Pharmacovigilance (drug safety)
  • Marketing and advertising of medicinal products and medical devices
  • Pricing and reimbursement
  • Professional codes of conduct and anti-corruption practices
  • Market withdrawals
We represent clients before the Bulgarian Ministry of Health, the Executive Drug Agency, the National Council of Prices and Reimbursement of Medicinal Products, the Transparency Committee, the National Health Insurance Fund, the Ethical Committee with ARPharM, the Consumer Protection Commission, the Bulgarian Patent Office, and try cases in courts of all instances, including the European courts.

We can help you by:

  • Review of internal policies and regulations for compliance with Bulgarian law;
  • Drafting industry-specific arrangements, including agreements with clinical research organizations, clinical trial agreements with principal investigators, laboratories, and healthcare organizations, distribution agreements, co-promotion agreements, cooperation agreements with patient organizations, donation and sponsorship agreements, non-interventional studies agreements, market research agreements, etc.
  • Compliance review of promotional campaigns and other advertising activities targeted to patients and health care providers (HCPs);
  • Legal advice on labelling and advertising claims;
  • Legal advice on compliance of companies’ internal policies and practices with the rules of ethics regarding relationships with health care providers (HCPs) and patient organizations;
  • Drafting complaints and answer briefs as well as representation of clients before the Ethical Committee of ARPharM;
  • Legal advice and representation of clients before the National Council of Prices and Reimbursement of Medicinal Products with regard to: registration, change, and deletion of drug prices; including medicinal products into the Positive Drug List and their withdrawal;
  • Drafting complaints against the pricing decisions of regulatory authorities and representing clients before the Transparency Committee and administrative courts of all instances;
  • Representation before the Bulgarian Patent Office with regard to registration of trademarks and patents, drafting of licensing, transfer of technology and know-how contracts.
Our life sciences group is supported by leading specialists in related fields, for the purpose of providing integrated advice tailored to the specific needs of our clients in the following key areas:

Key areas:

  • Structural of local presences and reorganization of representative offices and subsidiaries in Bulgaria
  • Commercial agreements
  • Consumer law
  • Data privacy and protection
  • Employee remuneration schemes for medical trade representatives
  • Intellectual property
  • Competition
  • Public procurement
  • Litigation
We remain attuned to prospective changes in the regulatory environment in Bulgaria and the EU. We conduct legislative analysis, draft opinions on proposed amendments to industry regulations and ethical codes of conduct, inform our clients timely on changes to the regulatory framework and practices of Bulgarian regulatory authorities, assist them in developing business strategies compliant from a legal perspective. Our ambition is to be a strategic partner who is on the side of our clients at every stage of their development and help them achieve their business objectives.