The regulatory landscape in Europe has become even more complex and requires specialists who know how to manage the application processes of different study types and product classes. We feel at home in the European legislation on clinical studies with medicinal products and medical devices, as well as in the national legislations. Based on your specific needs, we develop application dossiers that satisfy all relevant criteria. Our team interacts with the national and local regulatory authorities, as well as with ethics committees and institutional review boards in a coordinated effort to fulfill the regulatory requirements to conduct your project.
At FGK we are always up to date with the current regulatory requirements in Europe. We efficiently navigate your project through the complex meshwork of European regulations and guidelines and ensure compliance with the applicable international standards, e.g. ICH-GCP, ISO 14155 or ISO 20916.
Moreover, having created your successful clinical study application, FGK regulatory professionals support your project throughout its lifecycle and take care of the preparation and submission of amendments and notifications. With our regulatory advice, we help you to keep your project on track.