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Regulatory Experience

As former business executives, we have decades of hands-on, real-world experience being accountable for, and succeeding under, the following regulations:

• FDA GLP - clinical and nonclinical
• FDA QSR - including design control
• FDA GMP - food, pharmaceutical and medical device
• FDA 21 CFR Part 11
• EMEA Annex 11 and GMP Chapter 4
• DEA
• BIS (especially the "deemed" export rules) / ITAR
• HIPAA
• DoD - security aspects
• Bioterrorism Act

And the following international guidelines:

• ISO 17799
• ISO 15489
• ISO 17025
• ISO 13485
• ISO 14971
• ICH E6 - good clinical practice
• ICH Q8 - development
• ICH Q9 - risk management
• ICH Q10 - quality system
• GHTF - all
• National Archives (NARA) regulations
• European Union privacy rules
• ARMA International's best practices and standards for electronic and paper information

 

Email us at info[at]ceruleanllc.com to schedule a free 30-minute "no-sales-pitch" email or phone consultation - even if it's just to get a second opinion of someone else's recommendations or proposal.