Innovation and regulation
The healthcare and biotechnology sector is among the most sophisticated and highly regulated fields of activity. Companies developing medicines and medical devices, medical equipment manufacturers, contract research organizations (CROs), and healthcare service providers operate at the intersection of scientific progress, patient protection, and a complex legal framework that is continuously evolving.
TGZ Legal provides integrated legal services built on multidisciplinary expertise, combining corporate law, healthcare and pharmaceutical regulations, data protection (GDPR), international compliance, and intellectual property.
Navigating regulatory complexity to support innovation.
Who is this for
When you need us
We cover the full spectrum of legal needs in the medical, pharmaceutical, and biotechnology sectors.
Navigating the regulatory framework imposed by national authorities (ANMDMR, Ministry of Health) and European bodies. Expertise in the European Medical Devices Regulation (EU MDR), the Clinical Trials Regulation (EU CTR), and ICH GCP, including advisory services, among others, on the use and implementation of the UDI system, labeling requirements, and advertising rules.
We provide consultancy, negotiation, and contract drafting services for clinical trials, as well as other relevant intermediary arrangements. We manage key aspects such as intellectual property rights, protection of study subjects, indemnification and insurance, as well as payment terms. We facilitate relationships between contracting parties in the clinical field, ensuring the protection of their commercial and academic interests.
Consultancy services on the processing of personal and sensitive data (Article 9 GDPR), identification of the appropriate legal basis, drafting of data processing agreements (DPAs), and management of international data transfers (DPIA, SCCs).
In the medical sector, legal compliance programs ensure that corporate policies and internal processes meet regulatory requirements, safeguarding reputation and preventing legal risks. In M&A transactions, the focus lies on due diligence, contract negotiation, and the efficient transfer of Marketing Authorizations (MAs), ensuring business continuity and minimizing corporate risks.
MDR (Regulation (EU) 2017/745) is the new European legislation that radically tightens rules for medical devices. It imposes much stricter requirements regarding clinical evidence, post-market surveillance, traceability (via the UDI system), and advertising. Compliance is mandatory and complex.
Because it sits at the intersection of commercial and academic interests. The main bottleneck is usually intellectual property (IP). The Sponsor wants full ownership of the data they pay for, while the hospital/investigator wants the right to publish research results.
Consent (Art. 9(2)(a)) is a legal basis, but it is fragile because it can be withdrawn at any time. A robust legal strategy, especially for long-term research, will also rely on other grounds, such as Art. 9(2)(h) (necessity for the provision of health care) or Art. 9(2)(i) (public interest in the area of public health).
In the medical and pharmaceutical sector, the suspension or withdrawal of a product from the market is not caused solely by safety issues, but also by non-compliance with legal and regulatory requirements. Failure to comply with MDR/IVDR rules, errors in technical documentation, deficiencies in traceability chains, issues related to advertising or pharmacovigilance, or improper handling of health data may trigger severe measures by regulatory authorities. A preventive legal approach is essential to ensure continued market presence.
Non-compliance with Good Manufacturing Practice (GMP) requirements may entail significant legal and commercial consequences, ranging from the suspension of manufacturing or distribution authorizations to product recalls and substantial administrative sanctions. In addition, GMP deficiencies identified during inspections may negatively impact relationships with business partners, investors, and regulatory authorities. An integrated legal approach, aligned with GMP requirements and with the contractual structure of the supply chain, is essential to prevent such risks.