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Your Position: Home > CMC Quality Control Kit Validation Report Request Form
CMC Quality Control Kit Validation Report Request Form

CMC (Chemistry, Manufacturing, and Controls) applies to all phases of pharmaceutical development, with a focus on establishing consistency in drug product stability, release profiles, and manufacturing processes. It is essential to comply with regulatory guidelines and pharmacopoeial standards. To expedite the drug development process, we now offer validation reports from the third-party institution Eurofins, providing comprehensive support for regulatory submissions.

Level 1 Document: Covers key validation information (e.g., product characteristics, quality standards, test items and results), available free of charge upon evaluation.

Level 2 Document: Includes more in-depth process and validation data, available for purchase.

If you would like to request documents, please fill out the form below. We will get back to you as soon as the request is evaluated.

Information:

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SAFENSURE™ Mycoplasma Rapid Detection Kit (qPCR)(Cat.No. OPA-S102)
resDetect™ CHO resDNA Quantitation Kit (qPCR)(Cat.No. OPA-R004)
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Level 1 Document (Product validation summary, free)
Level 2 Document (Detailed quality and safety data, paid)
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