We have developed our regulatory and transactional practice in Europe to facilitate the diverse needs of our clients in the developing global market for medical products. Through our lawyers in our London, Brussels, Frankfurt, Tokyo and Washington offices, our practice is designed to provide clients with sophisticated advice on Europe and European markets; new centralized and mutual recognition regulatory systems for pharmaceutical products; emerging medical device directives; and related areas of medical product regulation.
Although many of our pharmaceutical and medical device clients recognize the significance of the European Union (EU) as a market, in many cases they are reluctant or unable to take the steps necessary to act due to a limited EU presence or limited international resources. We have structured our European regulatory and transactional practice to enable clients to overcome these limitations by effectively serving as their company abroad.
We assist clients in establishing their regulatory strategies, setting up clinical trials and providing the full network of experts needed for product development activity. Our contacts with the Competent Authorities responsible for regulating medical products throughout the EU can also facilitate product approvals.
In the case of pharmaceutical products, we work with clients using both the EU’s centralized and decentralized procedures. For medical devices, we regularly help clients locate the right Notified Body for their needs and give guidance on appropriate conformity assessment procedures that will permit them to certify their products as CE compliant. For both pharmaceuticals and medical devices, we have developed a variety of contractual and regulatory documentation for clients to use in clinical and product approval settings, and have identified pricing and reimbursement experts who can help our clients develop and implement parallel reimbursement and pricing strategies for the EU.
Our European practice recognizes that the needs of clients coming to the EU for the first time are not limited to receiving regulatory advice. Frequently clients must find distributors for their products, find partners for developing and marketing their products, and gain access to sources of European capital. Our practice is structured to meet these needs.
We often find and undertake due diligence reviews of potential distributors in the EU, drafting and negotiating the agreements necessary to establish such relationships. Our contacts with European-based pharmaceutical and medical device companies and trade groups also facilitate partnership opportunities. We frequently draft and negotiate collaboration agreements tailored specifically to EU regulatory and market needs. In addition, we advise on key issues such as crisis management, product liability, the reporting of adverse events, post-marketing vigilance and product recalls, as well as general commercial and trading issues.
We also understand that companies entering the EU need other nonregulatory advice in order to ensure successful market entry. For example, depending upon the company’s products and its regulatory strategy, it may be advisable for corporate and/or tax reasons for a company to establish a subsidiary in one or more EU Member States. We often work with pharmaceutical and medical device companies to match corporate, tax and other legal strategies with a company’s product marketing objectives.