Healthcare Compliance and Medical Approval

While in most international jurisdictions there is a legal basis for healthcare compliance, in practice it is common for the most comprehensive requirements concerning the advertising and promotion of medicines and other materials to be set out in codes of practice, i.e. under a voluntary system of regulation supported by bodies that help administer the codes. With their broad therapeutic experience, our experts are highly experienced in the review and approval of all materials that fall within the scope of applicable codes including promotional and non-promotional items, and internal materials.

In Europe, we will advise on and review activities and processes for healthcare compliance that fall under the EFPIA Code of Practice as well as national codes, practices and legislation. We aim to understand your commercial objectives so that both compliance and promotional effectiveness are achieved; with our constructive approach, we often advise on alternative solutions that achieve objectives. Where national requirements require the submission of certain materials to local health authorities, our combined regulatory and medical expertise is also highly valued by our clients. Furthermore, if you find yourself facing an authority inspection, our experienced audit team can assess your situation and provide you with actionable outputs so you can identify, correct and prevent risk. Our experts have successfully helped many companies with making and receiving complaints, investigations, appeals and audits.