Thanks for visiting us today! We offer Regulatory Inspection Training and Consulting Services to the Pharmaceutical and Device industry, as well as perform Quality Assurance Audits and Evaluations. We promise you the benefit of our longstanding experience delivered in a way that's not intimidating.
A brief glimpse of our GXP Audit Areas include: Sponsor, Monitor, Investigator, CRO, Pharmacovigilance, GCP [Drug, Biologic/Vaccine, Radiologic], Laboratory [GLP, Non-Clinical], cGMP [selected focus areas], Medical Device, Pharmacovigilance and Drug Safety, Submissions, Electronic Submissions, Electronic Systems, Validation of Computer Systems, electronic Health Records and Fraud Determination.
We have conducted over 800 GXP audits worldwide - examples include the following countries: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, England, Finland, France, Germany, Hungary, India, Ireland, Israel, Japan, Mexico, Netherlands, Norway, Peru, Spain, Sweden, Switzerland, United States, Uruguay, Wales.
We currently provide advice and training to regulatory authority personnel within the North American, Latin American, European and APAC communities. In 2012, Professor Hulihan was recognized as an “expert in his
field” as well as a “scientific expert” by several regulatory authorities.
We hope you can find everything you need to assist you in making your choice.
ew hulihan and associates are focused on providing high-quality consulting, training and educational services to the global Pharmaceutical and Device industry and achieving customer satisfaction - we will do everything we can to meet your expectations.
With a variety of offerings to choose from, we're sure you'll be happy working with us.
Look around our website and if you have any comments or questions, please feel free to contact us.
Our motto, "Integrity You Can Trust" is meant to represent the level of care with which we will extend on your behalf for your projects.
We strive to earn and maintain your trust through our partnership with you.