AQS provides skilled resources to assist companies in understanding and interpreting key regulatory concepts in order to make informed decisions in areas such as electronic record keeping, personnel qualifications, training, and validation. Through the use of risk management principles, AQS provides companies with valuable strategies that can be used in all areas of GxP compliance associated with the manufacturing, tracking and distribution of regulated products.
Our flexible delivery method adapts from an entire project to providing expertise and guidance at any phase of the process, from strategy development to data migration and system retirement.
For companies to market their products in the U.S. , we provide services for the FDA's Abbreviated New Drug Application (ANDA).
At AQS, we understand it is knowledge which will empower your organization to maintain a validated environment and create a defensible case for the U.S. FDA and European EMEA.