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Transferring your identity, purity, quantity, potency & general quality methods for your drug substance & drug product into a controlled, GMP-compliant environment.
Supporting phase specific validation throughout all phases of development (Phase I - III) & commercialization (Phase IV).
Covering all ICH validation parameters, according to Q2(R1) such as specificity, linearity, LOQ/LOD, range determination, accuracy, precision & robustness.
Taking into consideration:
critical reagents handling & bridging approaches.
establishment of reference & reference standard handling including storage.
providing a comprehensive validation protocol, report & validated method.
