Qualification & Validation
Our experts can transfer, qualify, and validate analytical methods from IND to NDA. We specialize in stability-indicating methods for aptamers, conjugates, and other complex nucleic acids. Method qualification is offered to support intermediate stage and later stage clinical programs.
Qualification and/or validation activities can be custom designed to meet specific client or country requirements. Analytical methods are developed, qualified, and validated for: raw materials, in-process testing, release testing, and stability testing. Robust qualified methods developed at the beginning of your program can save you time and money.