Our team assists our clients with preparing SOP's, Plans and Protocols for Laboratory Equipment Qualification, Analytical Method Validation, Analytical Method Transfer and Stability Stuides. The team works with our clients to trouble-shoot the analytical methods.
Development, implementation and maintenance of scientifically sound and validated analytical methods is crucial for the success of our clients in Pharmaceutical, Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredients (API) industry.
We help our clients with preparing for FDA and Customer Audits by performing Gap Analysis and Data Integrity Audits as well as by developing and implementing Remedial Action Plans.
Our laboratory experts have outstanding academic background and thorough understanding regarding compliance with FDA's regulatory requirements and applicable guidances.