Design and implement regulatory and scientific strategy for preclinical programmes through to early stage clinical. Advise or represent Clients in dialogue with regulatory authorities.
Outsourcing and CRO monitoring
Advise on cost-effective placement of nonclinical studies at Contract Research Organisations (CROs) and monitoring of CRO studies.
Interfacing to clinical trials
QSCL is expert in this activity due to the diverse and extensive experience of our staff.
For in- and out-licensing of drug candidates, QSCL provides a thorough review of the nonclinical dossier for completeness, technical competence, scientific and regulatory content, and assessment of data gaps and any regulatory issues. Attend meetings with licensee.
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