Regulatory Experience

As former business executives, we have 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
• DEA
• OSHA
• BIS - the "deemed" export rules
• HIPAA
• DoT
• DoD - security aspects
• Bioterrorism Act
• Sarbanes-Oxley

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
• National Archives (NARA) regulations
• European Union privacy rules
• ARMA International's best practices and standards for electronic and paper information

 

Call +1.757.645.2864 to schedule your free initial consultation or try our executive quick-start pack first.  There is no obligation or cost involved.