Product Quality Analysis

With a deep understanding of the latest regulatory developments, we can help our customers meet the regulatory requirements for authorization in all global regions, providing regulatory compliant data. Our experts will ensure the data meets the requirements of current Good Manufacturing Practice (cGMP), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), OECD GLP and other regulatory standards for investigational new drug application (IND) or new drug application (NDA) or biologics license application (BLA).