Cambridge Major strives to promote the concept of “right the first time – every time.” Quality control testing is of critical importance, due to the nature of our products. Testing at all stages of the process (raw materials, intermediates, and API) is critical, and is the cornerstone of our culture of prevention rather than detection.
The quality effort includes working with our customers to establish specifications, and then developing and implementing modern analytical techniques to ensure those specifications are met.
Cambridge Major provides a wide variety of analytical support services for development and manufacturing, consistent with the appropriate phase of drug development. Our method development philosophy is “fit for purpose,” meaning we will provide the appropriate level of development/validation to support your API based on where your compound is in the development cycle.
Cambridge Major’s Analytical Services:
- Stability Indicating Methods
- Determination of Residual Solvent
- Determination of Genotoxic Impurities
- Reference/Impurity Standard Qualification
- Cleaning Validation/Verification methods (specific and non-specific)
- In-process Controls
- Forced Degradation and Impurity Identification
- ICH Compliant Stability Program
World Class Analytical Facilities
Our facilities house state-of-the-art analytical laboratories and controlled environmental chambers to support ICH stability studies. Cambridge Major provides analytical support for in-process controls, quality control release testing, reference standard qualification, and method development/validation in compliance with FDA cGMP requirements and ICH guidelines Cambridge Major also offers comprehensive stability storage & testing by ICH guidelines. This includes ambient, intermediate, and accelerated conditions.
Method Development and Validation
Cambridge Major performs most compendial testing according to USP/NF, EP, BP, JP, and ACS monographs. This can be for raw materials, intermediates, or API release testing.
Contact us for more information about Analytical Sciences.