Development strategies definition
Offering phase-appropriate development strategies, aligned with clinical stage requirements and regulatory expectations. Guiding global development strategies, tailored to your product and target markets while considering your constraints.
Redaction of CMC documentation
Including development protocols, technical reports, risk assessments, regulatory documents (IMPD, IND, Module 3 of eCTD,...).
IMP supply
Coordinating the manufacture and supply of investigational medicinal products (IMPs) for clinical trials.
Managing the clinical supply chain, from production to delivery at investigational sites.