Capabilities at a glance
Analytical Development
cGMP-compliant Laboratories
Full suite of analytical tools
Method development services
Structure elucidation
Process Development
Route selection
Process optimization, including: Telescoping and reaction monitoring through PAT
Process throughput
Cleaning method development, validation and recovery studies
Manufacturing
Pilot/scale-up
Stability
Raw material sourcing
Cleaning validation
Process safety management
Starting material justification
Regulatory submission support
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Small Molecule API Development
With cGMP-compliant laboratories and a full suite of analytical tools, we offer comprehensive support throughout the entire development process of your small molecule API from initial discovery to commercial manufacturing. We have a range of analytical development and process development capabilities to suite your needs.
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Small Molecule API Manufacturing
As your API demand grows, we grow with you. While we can manufacture volumes in metric tons, we can also go small. If you have a chemistry-based compound and need smaller batches for clinical or commercial use, we can offer the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.
We work to scale with you, every step of the journey. We have a roster of analytical chemists, organic chemists and engineers who are adept at developing and troubleshooting analytical methods and processes and have the expertise to help scale up your API process.