Compliance Software Solutions & Compliance Outsourcing

Jack Garvey |

Scale without cost. These are watchwords to modern business. I want my operations to scale with my business volumes, but I don’t want to add cost -- How can I accomplish this in compliance operations?? Compliance Architects® is... Read more

FDA 483 & Warning Letter Response & Planning — DOs and DON’Ts

Jack Garvey |

If you are reading this now, you are probably in the middle of an enforcement crisis.   Responding to an FDA-483, Warning Letter, or in some cases, a product seizure or injunction can be one of the most important,... Read more

Pharmaceutical Company Subject of DOJ Sting, Story, Page 7

Jack Garvey |

Byline 1/19/2010, Legal Times DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal, compliance or risk-management leadership role inside an FDA-regulated company, and unless you’ve been... Read more