Development and Supply of Clinical Batches

From Phase I through Phase II/III, we enable GMP manufacturing, seamless tech transfer, and regulatory confidence — minimizing disruptions while optimizing cost, quality, and compliance. 

• Manufacturing of APIs across scales (grams to kilograms)  
• Formulated drug product (DP) supply — oral solids, injectables, liposomal suspensions, sterile formulations, and novel delivery systems 
• Lyophilization and aseptic processing support for sensitive biologics and RNA products 

• Technology transfer documentation, process knowledge capture, and knowledge management between discovery, process development, and manufacturing teams 
• Onsite or remote tech transfer support between CDMOs (lab → kilo → pilot → commercial scale) 

• Regulatory-author-ready documentation aligned with ICH guidelines 
• Risk-based control strategy and validation plans 
• QbD elements including critical process parameters (CPPs), critical quality attributes (CQAs), and design space documentation 

• IND/IMPD/CTA support including gap assessments and dossier review 
• GxP documentation review and remediation 
• Mock audits and preparation for FDA/EMA/PMDA inspections