ABOUT US

The Quantic Group is a pharmaceutical, biotechnology, vaccines and medical device specialty consultant that supports both the industry and governments; services are provided in multiple areas including: regulatory, research, development, manufacturing, and quality operations. For 20 years, Quantic has supported clients on a global basis, particularly in managing regulatory enforcement actions, which include prevention, remediation and certification of many major industry FDA consent decrees.

Quantic has provided expertise in such areas as: business, operational, marketing and manufacturing strategies; organizational structures; management controls; clinical trial practices; product research and development; manufacturing and quality systems methodologies and practices; compliance programs; bioequivalency studies; data integrity and accuracy reviews; FDA, EMEA and other regulatory matters; and FDA consent decree management and certification activities.