Niels Clauson-Kaas A/S is committed to operating in accordance with current Good Manufacturing Practice as defined by the current ICH Q7A Guide for Active Pharmaceutical Ingredients.
GMP projects at Niels Clauson-Kaas A/S generally begin at an early developmental stage, and produced intermediates and APIs are being used for pre-clinical and/or clinical testing.
The cGMP concepts and quality control measures applied to our activities are consistent with current industry thinking and regulatory requirements for the manufacture of APIs for clinical testing.
The process and the analytical methods used in the production of such materials occasionally change, as our knowledge of the process increases. All our work is performed under our SOP system, including full documentation and Quality Assurance involvement, approval/release decisions, investigations into unexpected or questionable results, and other appropriate QA functions.
Niels Clauson-Kaas A/S has been inspected and authorized by the Danish Medicines Agency to manufacture APIs for clinical trials.
