The pharmaceutical and medical devices industry is highly regulated, requiring specialised legal expertise to navigate the complex regulatory landscape. At our firm, we offer comprehensive legal services tailored to the unique needs of this dynamic and evolving sector. From product development and marketing approval to manufacturing and distribution, our attorneys provide strategic counsel to pharmaceutical companies, medical device manufacturers, healthcare providers, and regulatory bodies. We assist clients in ensuring compliance with applicable laws and regulations, protecting intellectual property rights, and resolving disputes effectively.
Our pharmaceutical and medical devices law practice area is dedicated to supporting clients through every stage of product development, regulatory approval, manufacturing, and distribution. With comprehensive expertise in regulatory compliance, IP protection, commercial transactions, compliance and risk management, and dispute resolution, our firm provides the legal foundation for success in this highly regulated and dynamic industry. Whether you are a pharmaceutical company, medical device manufacturer, healthcare provider, or regulatory body, our experienced attorneys are here to support you every step of the way.
Our firm offers a full spectrum of legal services designed to support every stage of the pharmaceutical and medical device lifecycle. Our deep industry knowledge and legal acumen ensure that our clients receive the highest level of support and advocacy.
Regulatory Compliance and Approval
Navigating the stringent regulatory environment is crucial for the success of pharmaceutical and medical device products. Our services include:
- Regulatory Strategy and Advice: Developing regulatory strategies that align with business goals and comply with Romanian and EU regulations.
- Marketing Authorisation Applications: Assisting in the preparation and submission of marketing authorisation applications to regulatory authorities such as the National Agency for Medicines and Medical Devices of Romania (NAMMD) and the European Medicines Agency (EMA).
- Clinical Trials: Advising on the legal aspects of conducting clinical trials, including protocol development, patient consent, data protection, and compliance with Good Clinical Practice (GCP) guidelines.
- Post-Market Surveillance and Reporting: Guiding clients through post-market surveillance requirements, adverse event reporting, and compliance with pharmacovigilance obligations.
IP Protection
Protecting intellectual property (IP) is vital in the pharmaceutical and medical devices industry. Our IP services include:
- Patent Prosecution and Litigation: Assisting clients in securing patents for new drugs, medical devices, and related technologies, and defending against patent infringement claims.
- Trademark Registration and Enforcement: Helping clients register and enforce trademarks to protect brand identity and market positioning.
- Trade Secret Protection: Advising on the protection of trade secrets, including the development of confidentiality agreements and internal policies.
- Licensing and Technology Transfer: Drafting and negotiating licensing agreements, technology transfer agreements, and collaborations to maximise the value of IP assets.
Transactions
We provide legal support for a wide range of commercial transactions within the pharmaceutical and medical devices sector, including:
- Research and Development Agreements: Drafting and negotiating agreements for joint research and development projects, ensuring clear terms and protection of IP rights.
- Manufacturing and Supply Agreements: Advising on manufacturing and supply agreements to ensure compliance with regulatory standards and secure reliable supply chains.
- Distribution and Sales Agreements: Structuring distribution and sales agreements to optimise market reach and comply with regulatory requirements.
- Mergers and Acquisitions (M&A): Providing comprehensive legal support for M&A transactions, including due diligence, transaction structuring, and integration planning.
Compliance and Risk Management
Ensuring compliance with industry regulations and managing risks is essential for sustaining business operations. Our compliance services include:
- Regulatory Audits and Inspections: Preparing clients for regulatory audits and inspections, and assisting with responses to findings and corrective actions.
- Anti-Corruption and Anti-Bribery Compliance: Developing and implementing compliance programs to prevent and address issues related to corruption and bribery.
- Data Privacy and Security: Advising on compliance with data privacy laws, including the General Data Protection Regulation (GDPR), and implementing data security measures.
- Quality Assurance and Good Manufacturing Practice (GMP): Providing guidance on quality assurance systems and GMP compliance to ensure product safety and efficacy.
Dispute Resolution
Resolving disputes effectively and efficiently is critical in the pharmaceutical and medical devices industry. Our dispute resolution services include:
- Litigation and Arbitration: Representing clients in litigation and arbitration proceedings related to regulatory compliance, IP infringement, contract disputes, and product liability.
- Mediation and Negotiation: Facilitating mediation and negotiation to achieve amicable resolutions and avoid protracted litigation.
- Product Liability Defense: Defending clients against product liability claims, including allegations of defective products, failure to warn, and breach of warranty.
Our attorneys possess deep knowledge of the pharmaceutical and medical devices industry, enabling us to provide tailored legal solutions that address the unique challenges and opportunities in this sector.
- Pharmaceuticals: Advising on the development, approval, marketing, and post-market surveillance of pharmaceuticals, including innovative drugs, generics, and biosimilars.
- Medical Devices: Supporting clients in the development, regulatory approval, and commercialisation of medical devices, from Class I devices to high-risk Class III devices.
- Biotechnology: Providing legal counsel on biotechnology innovations, including genetic engineering, biopharmaceuticals, and regenerative medicine.
- Healthcare Providers: Assisting healthcare providers in navigating regulatory requirements, compliance issues, and contractual relationships with pharmaceutical and medical device companies.