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We’ll help you conquer the complexities

Biosimilars are reshaping the future of modern medicine and while they may be similar in make-up to their biologic counterparts, or reference products, their development pathway presents a distinctly different set of nonclinical, clinical and regulatory expectations as well as substantial scientific and manufacturing challenges.

Our mission is to provide counsel and critical insights into FDA thinking throughout the biosimilar product development lifecycle. Our team of world-class consultants brings decades of experience at every stage:

  • 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.