A USA based medical device company approached Freyr for Regulatory assistance with Good Manufacturing Practices (GMP) audit for two of its facilities. To ensure that the project was carried out smoothly, it was required to audit all the GMP functions and procedures, right from manufacturing equipment, design control and development, quality management system, etc.
Read through the case study to know how Freyr managed to deliver high quality audit review documents as per the latest Regulatory standards of the USFDA, within two weeks.