The identification and design of the most appropriate, timely and cost-efficient preclinical development program provides you with reassurance of the relevance and applicability of the data to your intended clinical trial protocol or product registration.
Charles River has numerous scientific and regulatory advisors around the world with years of experience in the discovery and development of new chemical entities, biological products, and medical devices. Acting as consultants, program managers, and outsourced preclinical program directors, our experts use their specialized knowledge and experience to direct well-designed safety and efficacy programs that are critical to the success of a drug or device.
- Nonclinical program design for drugs, biologics, and combination products
- Nonclinical program review and refinement
- Review and interpretation of nonclinical studies
- Clinical study design based on nonclinical data
- EMEA dossier preparation
- Preparation/review of nonclinical sections of regulatory documents
- Preparation of integrated summaries for INDs/CTAs and investigator brochures
- Nonclinical gap analysis and due diligence
- Nonclinical representation at meetings with regulatory agencies
- Drug development training courses
For more information about our strategic consulting services, contact us at 1.877.CRIVER.1 or email@example.com.