R.P. Chiacchierini & Associates

R. P. Chiacchierini & Associates, with support from affiliated consultants, offers numerous services relating to quality systems and compliance for medical devices and biologic products. These services include:

Quality Systems

• The design, development and implementation of complete or partial quality systems that satisfy FDA, ISO 9000 and EN 46000 requirements, including Standard Operation Procedures, QA manuals and clinical trial systems, Design control systems, corrective action systems and product compliant reporting systems.
• Verification and validation assessments
• Process validation review and assistance
• Statistical process control
• Internal Quality Systems Audits
• Due diligence audits for suppliers, potential suppliers, acquisitions and CRO's

Compliance

• Audits of clinical data contained in regulatory submissions
• Quality assurance of internal operations, trial protocols/case report forms, sponsor to agency study reports and submissions, protocol implementation at trial sites and IRB's
• FDA compliance management, including FDA 483s, warning letters, consent decrees and recall strategies
• Assessment and preparation for regulatory inspections
• Assistance with agency representation and negotiation