We are manufacturing impurity Reference Standards in mg to gm level. We additionally do Custom synthesis of complex organic molecules as per customer requirement with cost effectiveness.
We understand the industry’s need for quality and reliability. Our analytical standards are thoroughly characterised and prepared in accordance with a robust quality system. We not only meet, but surpass the exacting pharmaceutical manufacturing standards necessary for the success of your project.
Method validations are performed to meet current ICH (International Conference on Harmonisation) guidelines. We can develop and write the protocol for method validations and protocols are developed and experiments are executed to FDA/ICH guidelines for method validation.
We followed Standard operating procedures (pharmacopoeial known method) are prepared and methods transferred to client laboratories, in case method is unknown we developed in-house method which relates with parent molecule by literature search or on the basis of customer method (Vendor qualification on MOU basis).
Analytical problem solving activities include identification of unknown peaks, evaluation of methods with exceipient products or processes and investigation of more expeditious and simpler analytical alternatives. The same implements are frequently used to troubleshoot processes, development and manufacturing a Compliance Analytical Lab.