Welcome to Professor Earl W. Hulihan Consulting

Thanks for visiting Professor Earl W. Hulihan Consulting! We offer high-quality Regulatory Inspection Training and Consulting Services to the global Pharmaceutical and Device industry, and perform Quality Assurance Audits and Evaluations. We will do everything we can to meet your expectations.We promise you the benefit of our longstanding experience delivered in a way that is not intimidating.

Click here for my full CV or read my Short Bio here

Contact me: 'earl at hulihan dot com'

For a full description of services offered, see the Our Services section, or read about my Professional Activities and Experiences.

A brief glimpse of 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, and Fraud Determination.

We have conducted over 500 GXP audits worldwide - example countries include: 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 agency personnel within the North American, Latin American, European and APAC communities.

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.