From technology transfer to finished-product supply — backed by 20+ years of regulatory work.
Integrated services designed to accelerate your pharmaceutical products from development to market.
Seamless transfer of manufacturing processes, analytical methods, and regulatory documentation. Our experienced team manages the entire transfer lifecycle for 75+ molecules across all therapeutic areas.
Each technology transfer package includes process validation protocols, analytical method validation, stability study designs, and complete regulatory documentation.
View Available Molecules
Leverage AI-assisted formulation optimization for small molecules, biologics, and complex generics. Our platform predicts stability outcomes, optimizes excipient selection, and accelerates development timelines.
Capabilities include pre-formulation studies, prototype development, scale-up optimization, and real-time stability simulations.
Dossier & CTD Services
Finished product supplied under exclusive licence for sterile injectables, oral solids, ophthalmic products, and topical formulations. Manufacture is placed with qualified partner sites named per programme, and each site's current GMP certification is provided with the dossier.
Supply includes the full regulatory package, certificates of analysis per batch, stability data, and remote support through registration.
Request Supply InformationComplete CTD/eCTD preparation, submission management, and deficiency response for global regulatory authorities.
Method development, validation, stability testing, and release testing for all dosage forms.
Primary and secondary packaging design, serialization, and regulatory-compliant labeling for all markets.
ICH-compliant stability programs including accelerated, long-term, and photostability studies.
Comprehensive QA/QC systems, deviation management, CAPA, and regulatory audit preparation.
Process scale-up from lab to commercial, equipment qualification, and process performance qualification.
Our team is ready to discuss your specific needs and develop a customized service plan.