Preclinical Research & Development Services
Our preclinical R&D team helps our clients develop research strategies to advance the development of their products. With the broad expertise of our in-house preclinical R&D team and our alliances, we provide consulting 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.
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
- Soliciting proposals, vendor assessments and contract negotiation
- Design of safety pharmacology and toxicology studies with providers
- Study Monitoring
- Report writing and preparation of submissions to regulatory agencies.
- Drug substance manufacturing, drug formulation and drug product manufacturing, evaluation of manufacturing facilities and conducting Quality audits and risk assessments.
We can assemble virtual pharma teams or integrate into your project teams working collaboratively with your staff to provide oversight and expertise to advance projects as rapidly as possible.
We routinely prepare detailed 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.