Pharmaceutical Contract Manufacturing Services

As a cGMP API manufacturer, our pharmaceutical contract manufacturing services can support the drug discovery process through all the stages of clinical trials from small volumes to multi kilos of API. Our capabilities in cGMP synthesis, analysis and sterile fill are regularly used to support the pharmaceutical and biopharmaceutical manufacturing industry.

Custom synthesis of classic small molecules and biopolymers are manufactured in our state-of-the-art cGMP facility. We are currently involved with small scale cGMP synthesis of active pharmaceutical ingredients in many drug classes. Some of the projects originated as contract research and others as custom synthesis. All are supported by our chemistry expertise, cGMP compliance and extensive quality control.

We are currently manufacturing sterile medical devices and sterile commercial products under GMP. We have manufactured many products for clinical trials (Phase I, II and III).

Validation
In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations from the norm could have unpredictable and sometimes devastating results. Therefore, Dalton pays special attention to equipment qualification and process validation to provide full regulatory compliance to its clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure your product is of the highest quality when it reaches its destination.

Dalton has capabilities to develop, create and execute validation protocols and studies required for your products and equipment that are required for your projects in accordance with current Guidelines (HPFBI, FDA, EP, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process, cleaning, aseptic and terminal sterilization processes, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical and decision making analysis is also part of the service.

We stand by our products which are manufactured to the highest quality standards. Click here to view our Product List.

If what you are looking for is not on the list please contact us at 1-800-567-5060 or 416-661-2102 or email us and we will gladly meet your pharmaceutical contract manufacturing needs.