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Take advantage of our global, real-world experience

Biologics Consulting has extensive experience in providing regulatory, product development and quality systems consulting services to developers and manufacturers of pharmaceutical products. Our team of world-class consultants brings decades of experience at every stage of the pharmaceutical regulatory and product development process.

This includes expertise in each of the following elements of the product development process:

  • FDA Submissions and Interactions
  • Pharmacology/Toxicology
  • Quality Management
  • Product Manufacturing
  • Medical Device Biocompatibility
  • Clinical Trial Design and Evaluation
  • GMP, GLP and GCP Regulatory Compliance
  • U.S. Agent Services

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.