Preclinical Strategy & Execution
Biotech & Pharmaceutical
For early-stage development needs, Cytopharma’s preclinical team is well-equipped to support you with strategic, technical and regulatory expertise.
Preclinical Strategy & Execution
Whether your product is a small molecule or biologic, Cytopharma can provide tailored assistance to help you plan and advance your program. This includes expertise in the complex CMC, safety and toxicology, and translational medicine aspects of today’s cutting-edge therapeutics.
Our preclinical drug development capabilities:
- Indication selection and definition of Target Product Profiles
- Drug discovery support, including target identification and validation, assay development, hit-to-lead, lead optimization and candidate selection criteria
- Development or review of preclinical development strategy plans
- Analysis of regulatory pathways for drugs and devices
- Design and management of in vitro and in vivo studies
- Chemistry, Manufacturing, and Controls (CMC) support through preclinical development
- CRO and CDMO selection, engagement and management
- Interpretation of preclinical study data and writing preclinical study reports
- Review of data in conjunction with market and regulatory frameworks to assist with go/no-go decision making
- Planning and execution of Pre-IND and IND meetings with regulatory agencies, including writing and submitting IND documents
Contact us
Discuss our consulting services for the pharma & biotech industries with us.