Healthcare, Pharmaceuticals, and Medical Devices

Other areas of expertise:

The healthcare, pharmaceutical, and medical devices sector is both highly regulated and extremely dynamic.

Companies face daily requirements related to clinical trials, marketing authorization, pharmacovigilance/materiovigilance, pricing and reimbursement, advertising, public procurement, data protection, and product liability.

Our team supports manufacturers, importers, wholesalers, distributors, pharmacies, private healthcare institutions, digital health and medtech companies in meeting regulatory obligations, accelerating market entry, and growing safely.

Why Zunic Law for Medical Law

End-to-end approach: from R&D and clinical trials, through registration, pricing and reimbursement, to commercialization, public procurement, and post-market obligations.
Industry understanding: pharmaceuticals, biotechnology, medical devices (including software as a medical device), e-health, and telemedicine.
Compliance and speed: practical steps, clear deadlines, and documents ready for regulators, partners, or courts.
Cross-border support: bilingual team (SR/EN), regional experience (Adriatic/Balkan), and cooperation with global manufacturers and startups.

Key Areas of Work

Clinical trials and research
Marketing authorization and variations
Pricing, margins, and reimbursement
Advertising, promotion, and gifts to HCPs/HCOs
Distribution, import/export, and serialization
Medical devices and IVDs
e-Health, telemedicine, and digital health
Data protection and confidentiality
Intellectual property and technology transfer
Public sector and procurement
Compliance, ethics, and competition
Product liability and disputes

A more detailed description of the key areas follows:

1. Clinical Trials and Research

Preparation and submission of documentation for regulatory approvals and ethics committees; contracts with research centers (CROs, hospitals, universities). We provide complete coordination among stakeholders, contract drafting, and alignment with national and international procedures.
Informed consent, sensitive data protection, secondary use of health data, and biobanking. We prepare consent forms, legal bases for processing, and ensure GDPR and local law compliance.
Compliance during studies: monitoring, SAE/SADE flows, responsibilities, and insurance. We advise on SOPs, adverse event documentation, and regulatory obligations.
Sponsor and investigator issues, including allocation of intellectual property rights and publication of results. We draft publication rights and protect know-how.

2. Marketing Authorization and Variations

Strategy and documentation for registration, wholesale/retail sales, parallel import, and OTC/Rx status. We support optimal market-entry strategies and regulatory compliance.
Variations, pharmacovigilance (PSUR, signal detection), labeling, and packaging. We handle documentation updates, labeling revisions, and regulator coordination.
Monitoring non-compliance and recalls, regulator and public communication. We prepare crisis plans, notices, and internal procedures.
Advice on “new medicine” status, biosimilars, and generics.

3. Pricing, Margins, and Reimbursement

Preparation and management of reimbursement listing procedures; negotiation of models (risk-sharing, commercial agreements). We support documentation, economic analyses, and risk-sharing models.
Compliance with price-referencing, discounts, bonuses, and transparency. We ensure contracts and offers comply with applicable rules and practices.
Analysis of pricing policies’ impact on market position and business model sustainability. We help plan long-term strategies and mitigate regulatory risks.

4. Advertising, Promotion, and HCP/HCO Relations

Rules for Rx and OTC advertising, disease-awareness campaigns, samples, sponsorships, and events. We advise from campaign concept to final material.
HCP/HCO interactions: prohibitions, restrictions, reporting, and internal policies. We draft policies and train teams to avoid regulatory risks.
Pre-launch review of campaign, brochure, and digital materials. We conduct legal reviews and approvals before use.

5. Distribution, Import/Export, and Serialization

Wholesale agreements, exclusivities, selective distribution; GDP/GMP obligations in contracts. We draft agreements and ensure compliance with good practice standards.
Serialization, traceability monitoring, and technical/legal interoperability with systems. We support system establishment and procedures.
Supply chain responsibility allocation and crisis planning (supply disruption). We structure contractual obligations and emergency plans.

6. Medical Devices and IVDs

Classification, compliance with standards, labeling, and post-market surveillance (materiovigilance). We advise on classification and documentation.
Software as a Medical Device (SaMD): intended use, updates, cybersecurity, and user notifications. We monitor the product lifecycle and post-market obligations.
Import/responsibility allocation (manufacturer, authorized representative, distributor, importer). We structure contractual relations and obligations.
MDR/IVDR transition and CE marking support. We prepare documentation and ensure EU compliance.

7. e-Health, Telemedicine, and Digital Health

Telemedicine platforms, mHealth apps, wearables, and HIS integration. We advise on regulatory status and contracts.
Validation of data and medical functionalities, terms of use, liability, and informed consent in digital settings. We prepare legal documents and policies.
Certification and post-market obligations for software solutions. We follow technical and legal requirements throughout the product lifecycle.

8. Data Protection and Confidentiality

Health data as a special category: legal bases, DPIAs, minimization, retention, and security measures. We document all steps.
Clinical data, patient registries, real-world evidence, and secondary uses; processor agreements (DPAs) and international transfers.
Contract and procedure alignment with GDPR.
Trainings and incident response plans for data breaches. We design protocols and support crisis response.

9. Intellectual Property and Technology Transfer

Patents, trademarks, design protection, trade secrets; SPC/extensions in pharma. We support registration and enforcement.
Licensing, co-development, know-how agreements, due diligence, and freedom-to-operate analyses. We assist in negotiations and reviews.
Innovation protection strategies integrated with commercial agreements. We design combined protection and commercialization plans.

10. Public Sector and Procurement

Strategies for participating in tenders for pharmaceuticals, medical devices, and services; qualification, appeals, and execution. We advise throughout the process.
PPPs and pilot projects with healthcare institutions: responsibilities and quality standards. We draft and manage project agreements.
Risk assessment of exclusion and anti-corruption breaches. We prepare internal policies and risk-mitigation plans.

11. Compliance, Ethics, and Competition

Anti-corruption policies in HCP/HCO interactions, gifts, travel, and sponsorships. We establish internal codes and training.
Competition law: rebates, exclusivities, selective distribution, information exchange, concentrations, and gun-jumping. We analyze business arrangements and merger procedures.
Internal whistleblowing procedures and investigations. We draft policies and support investigations.

12. Product Liability and Disputes

Civil and regulatory liability, product liability disputes, insurance, and recourse. We advise before, during, and after disputes.
Product recall strategies, corrective measures, patient/professional communication. We prepare crisis protocols and media communications.
Representation in litigation, arbitration, and settlement negotiations. We actively participate and represent before courts and tribunals.

Services We Provide

Regulatory and commercial advisory (continuous support for daily matters).
Preparation and review of documentation (registrations, contracts, policies, notices, consents).
Representation in administrative and judicial proceedings, inspections, and public procurement.
Training for legal, market access, marketing/sales, QA/RA, and IT/security teams (in-house and online).
Project management (market entry, post-market compliance, compliance programs, crisis response).

Who Engages Us

Manufacturers, importers, and distributors of pharmaceuticals, medical devices, and dietary supplements.
Private healthcare institutions, laboratories, CROs, and research centers.
Digital health and medtech companies (SaMD, mHealth, telemedicine).
Pharmacies and wholesalers, logistics, and cold-chain operators.
Insurers and healthcare service providers.

Typical Projects

Contracts: clinical trials (CRO/site), distribution/wholesale, licensing and technology transfer, DPAs and processor agreements, sponsorship/education, public procurement.
Regulatory documents and forms: dossiers and variations, PSUR/PMCF, pharmacovigilance/materiovigilance SOPs, patient/HCP notices.
Policies and procedures: advertising and HCP/HCO interactions, anti-corruption and transparency, data privacy/security, incident and recall playbooks.
Strategies and reports: market access and reimbursement, IP/compliance due diligence, competition assessments, portfolio risk-maps.

How Cooperation Works (4 Steps)

Discovery & Risk Scan — quick insight into products/services, processes, and goals; we identify “quick wins” and critical gaps.
Plan and Priorities — regulatory and commercial roadmap, responsibilities, and deadlines.
Implementation — preparation/review of documents, negotiations, proceedings, trainings, and SOPs.
Maintenance and Upgrading — regulatory monitoring, template updates, inspection/incident response.

Tijana Žunić Marić

Jelena Đukanović

Frequently Asked Questions (FAQ)

Can you handle full documentation preparation for registration and variations?

Yes, including coordination with technical/regulatory teams, labeling compliance, and regulator communication.

We prepare and track dossier submissions, variation strategies, and internal procedures to maintain documentation and minimize regulatory risks.

Do you cover digital health/telemedicine?

Yes. We assess whether software qualifies as a medical device, draft ToS/privacy/security requirements, and set post-market obligations.

We support certification, contracts with healthcare professionals and patients, and liability issues in case of medical errors or technical incidents.

We focus on GDPR, information system security, and international standards (MDR, IVDR, GDPR).

Do you support public procurement strategies and appeals?

Yes. We prepare documentation, assess risks, and manage appeals.

We develop competitive participation strategies, advise during qualification and evaluation, and represent clients before authorities in appeals and court proceedings.

We also plan long-term participation in framework agreements, negotiations with public partners, and contract execution with minimized risks.

Do you provide training for marketing/sales and medical representatives?

Yes. We organize practical training (in-house or online) on advertising, promotion, and HCP/HCO interactions.

Trainings cover legal and ethical rules, practical examples, case studies, and inspection simulations.

Programs are tailored from entry-level representatives to managers and compliance officers. Participants receive materials and checklists for daily use.

How do you protect innovations and brands?

We combine patents/SPCs, trademarks, and trade secrets with licensing agreements and integrate IP/competition clauses into commercial arrangements.

Beyond registration, we enforce rights through due diligence, competitor monitoring, and anti-counterfeit measures.

We also design commercialization strategies through licensing, co-development, or rights sales, ensuring innovations are legally protected and market-sustainable.