Services -- FDA Compliance & Enforcement

Inspections

   ♦  SOPs
   ♦  Training
   ♦  Audits
   ♦  Handling at the company during Inspections
   ♦  Responding to FDA Inspectional Observations (483s) 


Warning Letters & Untitled Letters

   ♦  Strategy and Remediation Implementation
   ♦  Drafting replies
   ♦  Liaison with FDA to ensure Close-out 


Formal Enforcement

   ♦  Import Detentions
   ♦  Seizures
   ♦  Injunctions and Consent Decrees
   ♦  Criminal Prosecution
   ♦  Application Integrity Policy 

   ♦  Debarment

   ♦  HHS Exclusion

  

Internal Investigations

   ♦  Conducting
   ♦  Report Preparation 


Recalls & Market Withdrawals

   ♦  Assessing need for recall
   ♦  Implementation
        • Risk classification process
        • Logistics
♦  Managing Products Liability Risks 


Good Clinical Practice (“GCP”) -- Compliance & Training

   ♦  SOPs –
        • drafting
        • review
   ♦  Compliance
        • audits
        • training
   ♦  Financial Disclosure Requirements – Compliance and Strategies
        • Federal:  FDA & HHS
        • Institutional (e.g., university, hospital)
        • Clinical trial design to minimize conflicts
   ♦  State regulatory requirements 

To see presentations and articles on Compliance & Enforcement, ...