REGULATORY & IP STRATEGY

Service Description

Innovation is only as impactful as its ability to reach the market — safely, ethically, and strategically. At APES, we support our clients in navigating the increasingly complex landscape of regulatory and intellectual property (IP) requirements. Our Regulatory & IP Strategy service ensures that your project is both compliant and commercially protected, from its earliest concept to full-scale deployment. We provide guidance on navigating regulatory frameworks, including but not limited to ISO quality standards, Good Manufacturing Practice (GMP), Life cycle assessment (LCE), Environmental, Social, and Governance (ESG) criteria, and sector-specific compliance requirements including MDR, IVDR, CE marking, HTA and EHDS compliance. Whether you are operating in health, deep tech, cleantech, or digital markets, we help you understand, interpret, and meet the standards essential for product certification, investment readiness, and public trust. We work closely with clients to build compliance roadmaps tailored to their innovation maturity level and strategic goals. Our regulatory support can be integrated at both the proposal and implementation stages, ensuring that legal and quality considerations are embedded in the project design — not added as an afterthought. This significantly increases evaluator confidence and reduces future barriers to scale. In parallel, we craft IP strategies using advanced tools like PatSnap®, a globally recognised analytics and landscaping platform. Through this, we offer a comprehensive view of the intellectual property environment in your domain, including freedom-to-operate analysis, competitive intelligence, and patentability assessments. Our support ensures that intellectual property is not only secured but also leveraged effectively — aligned with your go-to-market strategy, investment negotiations, and long-term growth planning. Whether you are protecting a novel algorithm, biotech innovation, or hardware platform, we help you identify the optimal IP structure, jurisdiction, and timeline. We also advise on IP exploitation, licensing, and co-development agreements, especially for clients involved in international consortia or public-private partnerships. Our approach balances innovation protection with collaboration flexibility — enabling you to build valuable alliances without compromising ownership.