Nonclinical Consulting Services

Our nonclinical development experts can help you expedite the completion of regulatory applications

Whether you need expert guidance to design your nonclinical program from the beginning, or whether you need experienced insight to conduct a gap analysis for an existing program, the nonclinical drug development consultants at Cardinal Health Regulatory Sciences have the proven knowledge you need.

We leverage decades of FDA and industry experience to strategically partner with you to create and implement customized nonclinical development programs that expedite the completion of regulatory applications. Our goal is to shorten your development timeline to get your products to market faster.

Proven regulatory expertise

Our nonclinical team is composed of industry experts and former FDA consultants, who average 18 years of pharmaceutical industry experience and collaborate across scientific disciplines. We’ve developed nonclinical programs in all major therapeutic areas, including small molecules, biologics, biosimilars, vaccines and devices.

Our suite of nonclinical services includes

  • Performance of nonclinical study audits to help assure compliance with Good Laboratory Practices (GLP)
  • Documenting, evaluating and justifying impurity levels in drug substances and drug products
  • Designing, preparing and submitting nonclinical sections of regulatory documents, such as investigator's brochures, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs)

Need nonclinical expertise?

We can launch new nonclinical development programs or fill gaps in current ones. Contact us today to put our nonclinical development experts to work for you.

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