Quality assessment of the registration dossier shortens the time required for marketing authorisation. The assessment allows for shortages/mistakes elimination at an early stage and supplement the critical shortages before submission of the documentation.
To assist in this highly complex process SciencePharma can prepare:
- opinions on possibilities for medicinal product registration,
- audits of registration dossiers with detailed assessment,
- assessment of bioavailability studies and other clinical and non-clinical studies,
- assessment of analytical methods used for quality control of raw materials and final products,
- assessment of Drug Master Files (DMFs/EDMFs) and technological documentation.
