Not if, but how
Lospa Lawyers is helping entities involved in the provision and facilitation of healthcare to innovate successfully, while anticipating and responding to complex regulatory and compliance challenges in Romania.
We understand the issues that healthcare companies confront and we have the experience, understanding of the law and skills to help our healthcare clients successfully navigate their daily and long-term challenges.
Our approach to all these matters is detailed and comprehensive and carried out with the utmost confidentiality. We have the knowledge, skills and expertise to assist pharmaceutical manufacturers, device manufacturers, providers and distributors in navigating the intricacies of the pharma business in Romania.
Our team has extensive experience of advising clients within the sector on:
- industry regulatory work including regulatory compliance: conduct of clinical trials, human tissue and pharmacovigilance; issuance of the marketing authorization for medicinal products; approval of the medicines’ prices; inclusion of medicinal products in the lists of reimbursed medicines approved by the healthcare authorities; the supply of medicines under public procurement proceedings
- commercial contracting, including marketing and promotion agreements; distribution, supply and logistic, manufacturing and franchise agreements; outsourcing agreements; procurement; IT and technology agreements
- pricing, distribution and reimbursement
- product liability and recall
- advising clients in respect of investigations by Romanian regulators, including the Romanian National Agency of Medicine and Medical Devices and Ministry of Health
- labelling, marketing and advertising medicinal products
- privacy and anti-corruption compliance, including policy work and regulatory investigations
- IP advisory work, strategy and litigation; trade mark filing; anti-counterfeiting and falsified medicines; licensing and technology/IP transfer; R&D; use of social media
- sponsorship of healthcare professionals, medical institutions and of scientific events
- the impact of the UK’s exit from the EU