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Proven success to give you an edge

The biologic product development framework brings regulatory challenges and complexities unseen in the traditional pharmaceutical development process. Biologics Consulting is a full-service firm offering the full-scope of regulatory and product development consulting for your biologic product.

Our team of world-class consultants brings decades of experience at every stage of the biologic regulatory and product development process. Our services include:

  • FDA Interactions & In-Person Meetings
  • Pharmacology/Toxicology
  • Quality Management
  • Product Manufacturing
  • Medical Device Biocompatibility
  • Clinical Trial Design and Evaluation
  • Immunogenicity Assessment
  • GMP, GLP and GCP Regulatory Compliance
  • U.S. Agent Services
  • Regulatory Applications & Submissions

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.