Quinz’s domestic regulatory and compliance practice offers comprehensive coverage to local affiliates of pharma, biotech and MedTech multinationals on domestic questions related to a company’s product’s lifecycle, spanning from the initial stages of (pre-)clinical development to the post-marketing phase. Our services encompass a multitude of domestic key topics, including in relation to clinical trials, early access and early reimbursement, post-trial access, marketing authorization procedures, pharmacovigilance, pricing & reimbursement, product samples, communications and interactions with patients and HCPs, advertisement, patient support programs, distribution of products, and parallel import/distribution. 

Our team advises other key players in the domestic life sciences market on various matters to ensure compliance with all applicable regulatory requirements. These matters include, inter alia, pricing and discount strategies of wholesalers, incompatibilities between regulated activities (e.g., wholesale vs. delivery to patients), mandatory public services by wholesaler-distributors, good distribution practices, cooperations between industry and pharmacies, requirements for establishments for human body materials (including intermediate structures and production establishments), domestic licensing requirements and standards for GMP production facilities, INN prescription and substitution of medicines, etc. 

Recent work highlights

• Quinz assisted the Belgian affiliate of a pharma multinational with headquarters in the UK, in relation to the pricing and reimbursement of one of its successful products. More particularly, Quinz provided legal advice to address the upcoming patent cliff and old drug cliff. 
• Quinz assisted a Dutch drug discovery and manufacturer of advanced therapy medicinal products (ATMP), in a project for the set-up of, and obtaining regulatory approval for, a manufacturing facility in Belgium for the production of ATMPs on the basis of induced pluripotent stem cells (iPSC). We provided the client with regulatory advice on the import and use of human body materials, and the requirements for obtaining regulatory approval for the production of ATMPs using iPSC.
• Quinz assisted the Belgian affiliate of a pharma multinational with headquarters in Italy, on matters of parallel import and parallel distribution of certain of its products. We successfully assisted the client in a cease-and-desist procedure against a parallel importer.  
• Quinz assisted the Belgian affiliate of a pharma multinational with headquarters in Switzerland on the set-up and implementation of early access programs, including advice on potential routes for early reimbursement. 
• Quinz assisted a Belgian academic institution in setting up the contractual framework for a ground-breaking and state-of-the-art research facility (bio-safety 3+ level), for the testing of vaccine candidates against various infectious diseases (RSV, dengue, pertussis, covid, etc.).