Non-Clinical Services

The early development of an appropriate non-clinical plan for your specific drug and indication is critical. The design of a non-clinical plan which is fully integrated with your clinical strategy is a complex process.

By relying on Dow’s non-clinical group, you will conduct at optimal times only those non-clinical studies necessary for the particular stage of drug development, avoiding unnecessary cost. Additional time and money are saved through the intelligent design of the specific non-clinical studies within the plan. To meet your clinical trial timing goals, non-clinical studies may be performed in a sequential fashion, or, to speed development, some or all studies may be performed concurrently.

Whether you are in need of development of a full non-clinical plan, design and management of a study, or interpretation of data, Dow has the expertise to advance your drug to IND, Proof of Concept in man and ultimately to NDA approval. You can benefit from Dow’s non-clinical expertise on a consulting basis or as the guide and manager for all of your non-clinical studies.

Specific Services

  • Design, review, and implement non-clinical programs and preclinical toxicology study protocols compliant with Good Laboratory Practice (GLP) regulations
  • Identify, qualify, and audit non-clinical toxicology CROs
  • Identify specific efficacy non-clinical models
  • Review, revise, and finalize non-clinical study reports for inclusion into regulatory submissions
    Prepare and review non-clinical regulatory documents (pre-IND, IND and CTA, NDA, eCTD, 510K)
  • Source and manage safety pharmacology, pharmacokinetic, and toxicology studies including:
    • Cardiovascular safety pharmacology
    • Dermal absorption and pharmacokinetics
    • Photosafety
    • Subchronic/chronic toxicity
    • Developmental and reproductive toxicity
    • Carcinogenicity, including transgenic models
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