Pharmaceuticals & Healthcare

Precision defines the pharmaceutical and healthcare industries — not only in science, but in law. The sector operates under an exceptionally detailed regulatory architecture where every product, study, and interaction is closely scrutinized. From laboratory to market, compliance is inseparable from innovation.

Pharmaceutical development, clinical research, and medical-device manufacturing all depend on strict adherence to EU and national rules governing safety, transparency, and ethical conduct. Each step — from clinical-trial authorization and pharmacovigilance reporting to advertising and market access — requires careful legal alignment with constantly evolving European frameworks.

We structure and negotiate agreements across the full product lifecycle: research collaborations, licensing, distribution, and technology transfer between healthcare institutions and private companies. Our work also covers pricing, reimbursement mechanisms, and compliance with healthcare-marketing and interaction codes of conduct. We ensure that relationships between manufacturers, professionals, and regulators remain transparent, compliant, and ethically sound.

The digital transformation of healthcare adds new legal challenges — from the use of patient data to telemedicine platforms and digital therapeutics. We design privacy and data-protection frameworks that allow innovation while safeguarding sensitive information, ensuring full alignment with GDPR and medical confidentiality requirements.

Relevant legislation:

European (EU)

Human Medicines Directive 2001/83/EC & Regulation (EC) 726/2004 (centralised authorisation)
Clinical Trials Regulation (EU) 536/2014
Medical Devices Regulation (EU) 2017/745 & IVDR 2017/746
Pharmacovigilance Regulation (EC) 726/2004 & Dir. 2010/84/EU updates
GDPR & e-Privacy (health data)
Cross-border Healthcare Directive 2011/24/EU

Bulgaria

Medicinal Products in Human Medicine Act
Medical Devices Act
Health Act;
Healthcare Establishments Act
Ordinances of the Bulgarian Drug Agency (BDA)