Method Transfer Services & Method Optimization Services
With expertise in custom synthesis, analytical services, and drug development.
We are here to support all your research needs by reducing the project timeline and cost.
With expertise in custom synthesis, analytical services, and drug development.
We are here to support all your research needs by reducing the project timeline and cost.
Method transfer in analytical chemistry involves transferring analytical methods from one laboratory to another while ensuring that the method performs reliably and consistently in the receiving laboratory.
Method transfer is important in pharmaceutical analysis because it allows pharmaceutical companies to replicate and implement validated methods across different laboratories, ensuring consistency, reliability, and regulatory compliance.
Method optimization involves improving the performance, efficiency, and robustness of existing analytical methods. It is necessary to enhance method sensitivity, reduce analysis time, and meet evolving project needs and regulatory standards.
ARSI ensures the successful transfer of analytical methods through a systematic approach that includes method evaluation, optimization, validation, comprehensive documentation, and training and support for the receiving laboratory.
ARSI offers a wide range of method optimization services, including robustness testing, parameter optimization (such as column and mobile phase selection, gradient optimization, and detector settings optimization), and forced degradation studies.
Yes, ARSI can optimize methods developed by other laboratories to improve their performance, sensitivity, and efficiency. Our optimization services are tailored to meet the specific needs of each client and project.
The duration of method transfer and optimization varies depending on the complexity of the method and specific project requirements. Typically, it can take several weeks to a few months. ARSI works closely with clients to provide accurate timelines and ensure timely completion of projects.
After method transfer and optimization, ARSI provides comprehensive documentation, including transfer protocols, validation reports, method SOPs, and optimization reports. This documentation supports regulatory submissions and quality assurance processes.
ARSI ensures regulatory compliance in method transfer and optimization by adhering to guidelines set by regulatory agencies such as the FDA, EMA, and ICH. Our transfer and optimization processes are designed to meet global regulatory standards.
Yes, ARSI offers training and technical support to ensure effective method transfer and implementation at the receiving laboratory. Our experts provide hands-on training and guidance to ensure successful method implementation.