At Zeta Analytical, we provide comprehensive analytical method development, validation, and transfer services. Our unwavering passion for quality ensures that we deliver nothing less than robust and reliable analytical procedures. This commitment to quality is not just a promise, but a guarantee that our services will help you maintain the highest standards of quality control and regulatory compliance.
Analytical Method Development
Our team of experienced analysts, with their in-depth knowledge and expertise, work closely with clients to develop customised analytical methods tailored to their specific products and regulatory requirements.
Through systematic analysis and subsequent method optimisation, we aim to develop methods that deliver accurate, precise, and reproducible results, meeting the highest standards of analytical excellence.
Whether it's assay determination, impurity quantification, or dissolution profiling, we have the expertise to develop methods that address the unique characteristics of each product, formulation or material.
Analytical Method Validation
We conduct thorough and meticulous method validation studies to demonstrate the accuracy, precision, specificity, and robustness of analytical methods in accordance with regulatory guidelines such as ICH and Ph Eur.
Our validation protocols include comprehensive experimental designs, statistical analysis, and acceptance criteria to ensure method suitability for the intended applications.
We assist clients in preparing validation protocols, conducting validation tests, and documenting validation results to support regulatory submissions and compliance with Good Laboratory Practice (GLP) requirements.
Analytical Method Transfer
We play a crucial role in the seamless transfer of analytical methods from CMO to routine testing at Zeta. Our services ensure that the methods are implemented consistently and reliably, despite the differences in facilities, thereby facilitating your operations and ensuring compliance with regulatory requirements.
Our internal method transfer protocols include comprehensive documentation, training, and performance verification to guarantee the successful implementation of methods in the receiving laboratory.
We work closely with sending and receiving laboratories to address any challenges or discrepancies during the transfer process, ensuring continuity and compliance with regulatory requirements. Our constant communication ensures that the protocol satisfies the desires of the CMO, MA holder, and us. Our reporting timelines and prompt client communication facilitate clearing any obstacles in method development in a timely manner, allowing routine testing to begin as soon as required.
Bespoke Analysis, Customised Solutions, Reliable Results
We understand that every analytical challenge and endeavour is unique. That's why we offer customised solutions and reports tailored to your specific needs, whether it's method development for a new product, transfer of existing methods, validation of established procedures, or even optimisation of current testing methods.
Our unwavering commitment to excellence, coupled with our extensive experience and technical expertise, ensures that your analytical methods meet the highest standards of quality, reliability, and suitability to your individual needs.
Get in touch
To discuss your analytical method development, validation and transfer service requirements, contact a member of the team.