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Qualification & Validation

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.

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