Analytical Services
Reliable analytical testing is what stands between a product and the market. Nichepharm provides the analytical support your commercial parenteral and biologic products depend on, from method development and validation through to routine release and stability testing.
Method development, validation, and transfer
We develop, validate, and verify analytical methods in our QC laboratories, building methods that perform accurately and reliably under our conditions and hold to current regulatory requirements.
Pharmacopeial testing and verification
Our team carries out pharmacopeial testing and verification to the standards your product must meet, including European Pharmacopoeia, USP, and ICH.
Stability studies
Our laboratories and stability chambers run studies across the conditions your product and its markets require, supporting both regulatory commitments and ongoing commercial monitoring, delivered on schedule.
Release testing
We perform the release testing your commercial product needs, including nitrosamines and elemental impurities, to the quality standards the sector demands.
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