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Our extensive FDA & industry experience gives you an edge

Biologics Consulting is a consulting firm with a medical device 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 projects and initiatives:

  • 513gs
  • IDEs
  • HDEs
  • 510(k)s
  • PMAs

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.

Every Step of the Way

We provide services to deliver impactful solutions at every stage of your product’s lifecycle, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization.

Not only do we want to guide you through each step of the process, we want you to achieve commercial success.