Preclinical R&D Planning and Execution Services

Our preclinical R&D team helps our clients develop successful research strategies that bring their products into clinical trials. With broad expertise in experimental science, our preclinical R&D planning professionals provide services that cover all aspects of the preclinical phase of development, from the initial scientific evaluation of candidate compounds and selection of clinical indications through planning and support of product manufacturing. Our Preclinical R&D planning staff provides our clients with comprehensive strategies to meet your needs.

Preclinical R&D Planning and Execution Core Services:

  • Technology assessment and evaluation, research strategy development, evaluation of competitive landscape
  • Assay design and preclinical animal model selection, study design and data interpretation
  • Lead optimization in both small molecules and protein therapeutics
  • Target product profile development
  • Establishing criteria for product characterization, purification and formulation
  • Nonclinical safety testing to support clinical development and commercialization, design and placement of safety pharmacology and toxicology studies with providers, preparation of documentation for submissions to regulatory agencies
  • Drug substance manufacturing, drug formulation and drug product manufacturing, evaluation of manufacturing facilities and conducting Quality audits

Our team integrates into project teams with your company and works collaboratively with your staff to provide oversight and expertise to advance projects as rapidly as possible.

We routinely prepare comprehensive product development plans that outline all activities from preclinical candidate nomination all the way through filing of marketing applications with the appropriate regulatory agencies. These “living” documents cover research, nonclinical development, clinical development, CMC and regulatory tasks and also include estimates of timelines and budgets for the entire development pathway of a product development candidate.