FDA Law Firm Support Case Studies

When Life Sciences Law Firms need to support their clients, they call Compliance Architects®. Founded by Jack Garvey, a leading expert-attorney in FDA-regulated compliance, quality, operations and regulatory matters, Jack possesses close to 30 years of hands-on leadership experience at top-performing life science companies including Johnson & Johnson, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories.

 

  • A DC law firm called us when they got the call from their client who explained they had a lot of batches of sub-potent hand sanitizer on the market.  We helped them through the recall efforts.  And more importantly, helped them develop a QMS system and processes to assure GMP compliance going forward.

 

  • Another well-known DC firm called when they had a client in need of consulting support. Their client was a small company with only one commercialized product and one product in development. An employee was alleging non-compliance with some cGMPs, including a lack of procedures in some key areas, lack of adequate resources devoted to compliance and failures to appropriately qualify equipment in use.  They wanted someone to review the company’s SOPs, do a gap analysis and also to do a facility audit.  Plus, make recommendations to ensure the company is doing what it should be doing.

 

  • DC law firm — with a non-US based client – asked us to help support the US regulatory process for clearance of a hydrogel for wound dressing.  Our work involved classification assessment, gap analysis of the technical documentation and acting as their US Agent.

 

  • Florida-based FDA attorney asked us to help him build a response for a new client’s Form 483.  The client was issued a straight forward – but multiple observation – 483.  The tough part was all seven of the observations were the same ones that were issued in a 2015 483 and subsequent 2016 warning letter.  We worked well with counsel to clear up the immediate distrust with FDA.  Plus, we built out a GMP/quality program that should ensure long-term compliance.  This particular attorney said he won’t do a Form 483 reply without Compliance Architects being involved.

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