Regulatory Alert: New FDA Proposed Rule — Sponsor Reporting of Falsified Data

Jack Garvey |

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more

Implementing an FDA-Regulated Quality System Using Microsoft SharePoint®

Jack Garvey |

New Jersey based pharmaceutical and medical device companies have a great opportunity this month to gain some significant information on how to improve their compliance outcomes and reduce their costs, using Sharepoint-based quality systems.    Sharepoint has become a... Read more

Bioanalytical Quality Standard Initiative

Jack Garvey |

Jack Garvey, Founder of Compliance Architects LLC is Co-Chair of the Bioanalytical Quality Standards Initiative.   This initiative, conceived by Synomics Pharma Services, was founded to respond to years of inconsistent guidance and enforcement surrounding bioanalysis in support of... Read more