Healthcare, pharmaceuticals and medical devices — clinical trials, marketing authorisation, reimbursement, promotion, data protection and product liability.
Contact usThe healthcare, pharmaceutical and medical devices sector is both heavily regulated and fast-moving, which makes specialist legal support essential.
Companies face daily requirements on clinical trials, marketing authorisation, pharmacovigilance and materiovigilance, pricing and reimbursement, advertising, public procurement, data protection and product liability.
We support manufacturers, importers, wholesalers, distributors, pharmacies, private healthcare institutions, and digital health and medtech companies in meeting those obligations, entering the market faster and growing safely.
The approach runs end to end: from R&D and clinical trials, through registration, pricing and reimbursement, to commercialisation, procurement and post-market obligations, in Serbian and English across the region.
Twelve areas of work across the product lifecycle.
Four steps, from the first risk scan to ongoing maintenance.
A quick view of products, processes and objectives, identifying quick wins and critical gaps.
A regulatory and commercial roadmap with responsibilities and deadlines.
Preparation and review of documents, negotiations, proceedings, training and SOPs.
Regulatory monitoring, template updates and response to inspections and incidents.
A sample of recent work in the sector.
CRO and site agreements, wholesale and distribution, licensing and technology transfer, processor agreements and sponsorship.
Dossiers and variations, PSUR and PMCF, pharmacovigilance and materiovigilance SOPs, patient and HCP notices.
Policies on advertising and HCP interactions, anti-corruption and transparency, data privacy and security, incident and recall playbooks.
Market access and reimbursement strategy, IP and compliance due diligence, competition assessments and portfolio risk maps.
Yes, including coordination with technical and regulatory teams, labelling compliance and communication with the regulator.
We prepare and track dossier submissions and variation strategies, and set the internal procedures that keep the documentation current.
Yes. We assess whether software qualifies as a medical device, draft terms of service, privacy and security requirements, and set post-market obligations.
We support certification, contracts with healthcare professionals and patients, and liability questions in medical error or technical incident scenarios, working to MDR, IVDR and GDPR.
Yes. We prepare the documentation, assess the risks and manage appeals.
We advise during qualification and evaluation, represent clients before the authorities and in court, and plan participation in framework agreements.
Yes — practical training, in-house or online, on advertising, promotion and HCP and HCO interactions.
Sessions cover the legal and ethical rules with case studies and inspection simulations, tailored from entry-level representatives to compliance officers.
We combine patents and SPCs, trademarks and trade secrets with licensing agreements, and build IP and competition clauses into the commercial arrangements.
Beyond registration we enforce rights through due diligence, competitor monitoring and anti-counterfeit measures, and design commercialisation strategies through licensing, co-development or sale.
Tell us what you are registering, running or launching and we will map the regulatory path.
Contact usRecent writing on clinical research, health data and security.
Legal developments in Serbia and the EU, each with the step it asks of your business.
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