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 QTPP, development protocols, batch records, technical reports, risk assessments, gap assessments, regulatory documents (IMPD, IND, Module 3 of eCTD,...).
IMP supply
Coordinating the manufacture and supply of investigational medicinal products (IMPs) for clinical trials (from Phase 1 to Phase 3).
Managing the clinical supply chain, from production to delivery at investigational sites.