Biotech and MedTech companies holding a promising (first) product candidate in their portfolio often encounter various legal hurdles when aiming to bring their innovations to the European market. We have assembled a multidisciplinary team of experts to guide our clients through all legal and compliance challenges associated with the development and commercialization of their technology and to ensure that they are ready to (timely) launch their (first) product on the market or to out-license it to a third party at the most advantageous moment.
We assist our clients in selecting and securing their strategic R&D and supply chain partnerships and support their efforts to raise external funding (e.g., by joining national or international funding programs or consortia), always carefully preserving the client’s freedom to operate and potential improvements to their IP portfolio. We provide assistance in the deployment of the (multi-center) clinical study network (CRO and clinical sites) for their (first) product candidate.
We help our biotech and MedTech clients to gradually meet the complex requirements under GDPR and healthcare compliance standards. We assist our clients throughout the various regulatory challenges of their product development and commercialization, including on (early) market access strategies, and the pricing and reimbursement of their technology.
We assist our clients in all business development-related transactions during the development phase, such as strategic co-development, in-licensing of new technologies, or out-licensing of indications or territories.
Finally, we support our clients with challenges that are not strictly related to the life sciences sector but that are inherent to their growth: set-up of local corporate presence throughout the EU; compliance with local labor and social requirements; management of procurement-related contracts (support services contracts, consulting contracts, IT software development or licensing agreements, etc.).
Recent work highlights
- Quinz has supported a Dutch clinical-stage biotech company with the valorisation of its IP portfolio, including the negotiation of out-licensing agreements with a US-based pharma company, in-licensing agreements with academic institutions, and various R&D and supply chain-related agreements. In addition, Quinz has supported the client with the entirety of its clinical trials in Europe.
- Quinz has assisted the Belgian, Dutch, and Luxembourg teams of a clinical-stage US-based biotech company, with regulatory advice on matters related to market access and P&R, disease awareness initiatives (including sponsored genetic testing), and patient support programs (including sponsored home care).
- Quinz has assisted a Belgian biotech company in the transfer of the majority of its assets and the out-licencing of its technology to a strategic partner, a company specialising in drug delivery systems for cell and gene therapy.
- Quinz has advised a US-based clinical-stage biotech, with teams throughout the EU, on a wide range of regulatory and compliance related matters. Quinz has advised the client in determining an appropriate early access strategy for the company to enable access for patients to its medicinal products prior to the commercialization and reimbursement thereof on the Belgian market. In addition, Quinz has supported the development of the internal policies of the company to ensure clear, compliant and efficient procedures to handle requests for early access, and has advised the client in the negotiation with the NIHDI of reimbursement agreements for its products.
- Quinz has advised a Swiss-based biotech company on the various ways to ensure post-trial access to their medicines in Belgium, Finland, Italy, Korea, Poland, Spain and the United Kingdom. Based on this analysis, Quinz has advised on the adequate product access strategy in each of said jurisdictions.
