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European Union Life Sciences Regulatory
SJKP LLP’s comprehensive European Union life sciences practice combines deep regulatory expertise with hands-on capabilities in Brussels and key EU member states.
We support European and global pharmaceutical, biotech, and medical device companies—from innovative startups to established multinational corporations—in establishing and expanding their global footprint in the life sciences sector. Our team provides expert guidance through the complex cross-border regulatory and economic challenges of conducting global clinical trials and commercializing medical technologies across Europe.
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1. European Union Life Sciences Regulatory Support Across the Product Lifecycle
SJKP LLP provides counsel to life sciences companies at every stage of the product lifecycle. From developing effective clinical and pre-clinical testing programs to securing patent and regulatory exclusivity, we help our clients achieve long-term success in the European market.
Clinical Trials and Market Launch Strategy
Our team guides clients through the complexities of global clinical trials, ensuring compliance with European regulatory requirements while addressing international data privacy and patent implications. We help design and implement clinical trial strategies that support European approvals, ensuring our clients meet the necessary regulatory standards for product commercialization.
2. European Union Life Sciences Regulatory Post-Market Compliance and Safety
Following product launch, SJKP LLP assists clients with compliance issues related to manufacturing, marketing, distribution, and safety. We help companies navigate post-market requirements, including recalls and other safety-related actions, and provide expert advice on responding to governmental investigations and enforcement actions.
Ensuring Continued Compliance
We provide ongoing counsel to ensure that life sciences products remain compliant with EU laws and regulations throughout their lifecycle. Our team helps companies stay ahead of regulatory changes and address compliance issues proactively, ensuring smooth operations and continued market access.
3. European Union Life Sciences Regulatory Cross-Border Investment and Regulatory Coordination
SJKP LLP’s EU team works closely with our colleagues in the US and around the world to ensure seamless regulatory compliance and market access. Whether seeking parallel approvals from the US Federal Drug Administration, designing global strategies for data privacy and patents, or pursuing cross-border investments, we offer integrated and efficient counsel tailored to each client’s needs.
Global Coordination and Efficient Counsel
Our cross-border expertise ensures that clients receive coordinated, efficient support to meet their global regulatory needs. We help navigate the complexities of international laws and provide actionable guidance for clients looking to expand into new markets or make strategic investments.
The information provided in this article is for general informational purposes only and does not constitute legal advice. Reading or relying on the contents of this article does not create an attorney-client relationship with our firm. For advice regarding your specific situation, please consult a qualified attorney licensed in your jurisdiction.
