• Strategic advisory: We help with communications, regulatory submissions and meetings, including preparation or attendance at Health Authority meetings. We’re also there for consent decree remediation and verification activities, as well as Form 483 and Warning Letter responses. We can also provide a loaned executive service when more substantial support is needed.
• Auditing: We assist with general GxP audits, FDA-type mock PAIs and other inspections (including both on-site or virtual), verification audits and effectiveness checks, and gap analyses. We can also consult on good distribution practices, quality systems, and management control.
• Data integrity: We provide directed audits and analysis, subject matter training, procedure development, interviews of staff, internal investigations, and fraud evaluation. Throughout the process, we coordinate our efforts with your legal counsel.
• Inspection support: We provide hosting, front/back room support, mock interviews, readiness assessments, and application conformance reviews. We help you prepare by reviewing hosting processes, site presentations, and tour routes.
• Technical writing: Our writers assist with SOPs, validation protocols and reports, annual product reviews, FDA correspondence, audit responses, strategic plans, and other technical reports.