Helping our clients go further
The Pharmaceuticals & Life Sciences team at Filip & Company is comprised of industry experts ready to help in the highly complex healthcare sector in Romania. Our team possesses very good technical and economic knowledge on the local realities, being involved in projects handling various regulatory & compliance aspects of a wide range of legal and contractual matters, such as:
- authorization and notification aspects in relation to pharmaceutical and non-pharmaceutical products (medical devices, food supplements, etc.);
- assistance and representation before the Ministry of Health and the National Agency for Medicines and Medical devices with respect to various regulatory topics, such as pricing, reimbursement, compliance with the legal framework on advertising and marketing with respect to both pharmaceutical products and medical professionals, etc.;
- preparing and assessing various commercialization models covering the entire distribution chain;
- assistance with respect to (public) tender procedures, National Health Programs, etc.;
- regulatory aspects concerning clinical trials, including preparing and reviewing the contractual framework between sponsors, CROs, hospitals and medical professionals, patient enrolment, etc.;
- draft and review of agreements with suppliers, distributors and other stakeholders;
- draft and review of contractual framework with medical professionals, including aspects concerning clinical trial, sponsorship and donations;
- due diligence and authorization aspects regarding hospitals and health clinics;
- assistance and representation in relation to the setting up of hospitals, health clinics and medical clinical trials units and pharmacies, including regulatory aspects.
Review of promotional and marketing materials aimed both for professionals in the medical field, as well as for all relevant stakeholders.
- assisting a German multinational pharmaceutical and life sciences company in relation to the restructuring of its dealers’ network, including regulatory advice and drafting and negotiating the distribution contracts; advising the client with respect to various commercial matters, including hospital tenders, unfair practices by certain distributors and competitors, etc.;
- assisting a European producer of high-quality medicines in various disputes related to trademarks. These involved a counterfeit claim, aspects of cancellation of the trademark held by the adverse party and the withdrawal of products from the market;
- assisting one of largest networks of medical laboratories in relation to the impact of a merger on the authorizations, approvals and permits specific to the laboratory and clinical trial medical activity;
- assisting one of the largest healthcare services providers in Romania with respect to the required authorizations and permits concerning the acquisition of a hospital in Romania;
- constant legal assistance to one of the most important central laboratories for clinical trials in Romania, active at international level, in relation to the review and preparation of framework contracts for clinical trials, including the settlement of certain legal aspects related to the cross-border provision of services in the context of clinical trials, the relationship with the regulatory authorities, advising on the regulatory aspects related to cooperation with pharmaceutical companies and healthcare providers, as well as the preparation of contracts and documents in the context of the biobanking activity; assistance in relation to complex personal data protection aspects in the context of clinical trials and biobanking activities.