Our team of consultants have an average of 35 years of experience and are experts at interpreting and applying regulations, ensuring your organization’s compliance with applicable regulatory rules and guidances.  Furthermore, our SME’s are current and fluent with industry standards  and regulations such as FDA, EU, MHRA, ISPE, and ISO.  We have successfully assisted many of our clients during regulatory inspections focused on 21 CFR Part 11 as well as EudraLex Annex 11.