Complete transfer of master formulas, manufacturing processes, stability studies, and CTD/eCTD templates via secure digital portal. 70+ molecules available.
Custom dosage form development compliant with USP standards. Lyophilization, PEGylation, microspheres, nanoparticle formulations, and sterile injectables.
Single-dose, repeat-dose toxicity, genotoxicity, carcinogenicity, and pharmacokinetic studies for IND and NDA submissions.
Scalable GMP manufacturing for injectables, biologics, cytotoxics, and controlled substances. Fill/finish with isolator technology.
Dossier preparation for FDA, EMA, Health Canada, TGA, and PMDA. Full ICH compliance with PIC/S standards.
End-to-end trial design, site management, monitoring, and reporting from Phase I through Phase III.
Method development, validation, dissolution testing, impurity profiling, stability studies, and release testing.
Global distribution with cold chain logistics, GDP-compliant warehousing, and product integrity management.
Round-the-clock specialist access. Know-how documentation delivered within 2–21 business days.
Quality & Compliance
GMP compliant · Health Canada, FDA, EMA, TGA, PMDA submissions · Vancouver, BC