Quality and Accuracy
We interpret, practice, and perfect complex USP methods, as well as understand and implement most of the methods published in the FCC. Once we have undertaken a project, we pore through the data to ensure complete accuracy. The validation reports we then create are complete with all supporting documentation, data, explanations and are transparent with in-depth validations.
Personalized & Customizable Service
Our client’s interests are consistently met and exceeded through reliable, friendly and professional service. We aim to keep open and ongoing communication lines with all our clients throughout the testing period in order to make sure that your tests are done right, and that your needs are met.
Additionally, we can also create a method for your product, validate it, and create a Standard Operating Procedure (SOP) for that method. On the flip side, if you already have established in-house methods, we can also follow the methods you provide.
To satisfy your quality objectives and to meet regulatory requirements, we follow a rigorous quality assurance program. All analyses performed in our laboratory meet strict compliance as described in Current Good Manufacturing Practices (CGMP) and Current Good Laboratory Practices (CGLP). Procedures control all aspects of analysis including sample submittal, calibration, analysis of samples, data reporting and records management. Our QA program provides continuity and control to perform all aspects of analysis in a defined and systematic manner.
Data integrity is fundamental to our quality assurance program, and we adhere closely to CGMP guidelines on data integrity in order to ensure complete, consistent, and accurate data. Our policies extend to the management of documents and electronic records, as well as training for all employees.
We write solid, comprehensive protocols that withstand FDA scrutiny, and we closely guide our clients through the process. We also ensure that our clients understand what is contained in the reports by thoroughly explaining, clarifying, and answering any questions.