We provide analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.
Each regulatory submission must include the appropriate analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product, including bioavailability. Our methods development and validation service works to deliver the data that must be available to establish that the analytical procedures used in testing meets the proper standards of accuracy and reliability whilst meeting regulatory expectations.
The principles of methods development and validation apply to all types of procedures, however; pharmaceuticals that are derived from biotechnological/biological processes may have distinguishing characteristics which necessitate more complex analytical methodologies.
Our method development and validation service offers the development and validation of regulatory compliant procedures ranging from conventional HPLC through to complex monoclonal and polyclonal bioassays that can be routinely used to support either stability testing or lot release testing in the discovery, development and manufacture of pharmaceuticals.