The regulatory landscape is constantly changing. Our large staff of former FDA and industry experts ensure you stay on top of it all. Whether you need help preparing submissions or need to staff your internal team with an experienced expert, we help you navigate complex regulatory challenges, bring your products to market, and keep them there.
Some deadlines have passed. Others are approaching fast. The European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) increase the scope and stringency of regulatory expectations for those marketing devices and some diagnostics in the EU.
We can ensure your organization is in a complete state of compliance readiness no matter where you are in transition.
Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in aggressive and complicated areas.
The Functional Service Program (FSP) is a bundled engagement option that consolidates your externally-sourced projects through a single vendor in The FDA Group. By streamlining vendor management, our FSP eliminates inefficiency, reduces budget overruns, and provides high-quality services from the industry's top talent. Discounts scale with the size and duration of the service package and include a Total Quality Guarantee to ensure reliable service.
Our resources can be utilized to meet the wide range of regulatory requirements, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about fulfilling specific regulatory affairs resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.