With the scrutiny placed on analytical method validation, you’ll want a partner with specific expertise like ours

Sound method development and validation is vital to ensuring quality and reliability of test results, and its documentation is needed to demonstrate procedural suitability. CritiTech has assembled a team with extensive analytical method development and validation expertise, with years of pharmaceutical experience and the innovation to solve any analytical challenges that you may be facing. Precise pharmaceutical analytical development practices are a must in today’s highly regulated industry. A meticulous protocol in this regard is no longer just a requirement; rather, it’s the cornerstone of successful drug development.

From a material identification, quantification and purity perspective, we utilize a range of advanced techniques including UV/Vis, GC, and HPLC method development for pharmaceutical projects. We provide our customers with transfer, verification and validation of USP and non-pharmacopeia method (including specificity, linearity, accuracy, precision, limit of detection, limit of quantization and robustness).  

CritiTech also specializes in analytical method development for API and/or drug product detection, separation and quantification, as well as improvement of early stage methods for faster throughput and/or enhanced separation. For material characterization, we provide our customers with transfer and validation of particle sizing methods, development of new methods employing multiple techniques (including a wide range of dispersion methods and dispersants), state-of-the-art specific surface area/porosity measurement and understanding, and visualization/confirmation of methods/results through the use of in-house scanning electron microscopy. 

Our team offers these services with the same timeliness, attention to detail and quality oversight that it provides with all of its other drug development and particle engineering services. 

Why Choose CritiTech?

Choosing to work with CritiTech for pharmaceutical analytical development and method validation means your company gains the benefit of our years of expertise. In addition to our experience in drug method development, quality assurance and long history of innovation, we also bring a customer-centric approach. This means we take your unique requirements and challenging into consideration every time we undertake a project on your behalf. To learn more about how we can assist with analytical development in the pharmaceutical industry, reach out and speak with a member of our team today.