We’re widely recognized within the life science industry and global regulatory agencies for our ability to help companies successfully resolve complex regulatory challenges. By mining regulatory intelligence, we continuously evaluate the FDA’s current thinking and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
Our breadth of expertise in the Medical Device industry is globally renowned and in demand. Our services include regulatory affairs, assessments and audits, agency response, preparation and remediation, and strategic consulting on new product development, lifecycles, and staffing support.
Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.
Client Mid-size Industry Pharmaceutical and Medical Devices Business Challenge Develop a sustainable operational business model for PV, DV, CM, and MI that will meet increasing business demands and escalating regulatory requirements. Project Timeline Pre-Implementation Due Diligence – 3 Months Pilot...Read More