We are currently involved in the small scale cGMP contract manufacturing of active pharmaceutical ingredients in many drug classes. Many of the APIs we currently manufacture started with us as a Contract Research Project or as Custom Synthesis Projects. Our integrated services offer allow our customers to move their API products from inception all the way through to cGMP manufacturing all in one company. Dalton brings more than 25 years of chemistry experience to all API synthesis projects and we ensure cGMP compliance with our rigorous quality systems.
API Synthesis Validation
At Dalton we pay special attention to equipment qualification and process validation to provide full regulatory compliance for our cGMP API manufacturing clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure that your product is of the highest quality when it reaches its destination.
Dalton can develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (U.S. FDA, Health Canada (HPFBI), EMA, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process validation, cleaning validation, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical analysis and decision making analysis are also part of our service.