Our extensive FDA & industry experience gives you an edge
Biologics Consulting is a consulting firm with a medical device, combination product and IVD focus. Our comprehensive experience providing regulatory, product development and quality systems consulting services to manufacturers of medical device products makes us a global leader.
Our team has knowledge and hands on experience with hundreds of successful domestic and international registrations and projects:
Pre-Subs | 513(g)s | IDEs | HDEs | 510(k)s | PMAs | De Novos | QSRs | CE Marks
Let’s drive public health forward, together.
Medical devices continue to play a vital role in the advancement of modern medicine – from neurostimulators, implantable defibrillators and joint replacements to crutches, wearables, medical softwares and in vitro diagnostics (IVDs). Working with Biologics Consulting means working with a consultancy that was founded on the premise that better devices hold the promise of a better future for patients.
We bring together innovative approaches, world-class science, regulatory know-how and a dedicated team to deliver solutions that make a positive impact on public health and quality of life for patients.
Our medical device consulting process
Whether your proposed device is an improvement on an existing product or a revolutionary breakthrough, our team brings decades of FDA and product development experience. Not only do we want to help you navigate each part of the review process, we want to facilitate commercial success.
Learn, understand and assess the client’s needs.
Research, collaborate and plan the pathway to success.
Align strategically and draft an action plan.
Execute and finalize the strategic plan and next steps.
Ready to change lives?
Meet our medical device specialty group
Our expertise spans the full spectrum of the medical device product development pathway. In each client engagement, we view ourselves as a success partner and a member of the medical device development team.