Recall Readiness Assessment

AlphaPath evaluates your current recall procedures, roles, and tools to reveal hidden gaps before a crisis hits. The service includes a structured review of SOPs, traceability, training, and communication plans, followed by a prioritized action roadmap so your team knows exactly what to fix, in what order, and by when.

Recall Execution Support

When a field action or recall occurs, AlphaPath provides hands-on leadership from scoping and risk assessment through product retrieval, documentation, and FDA-facing updates. Support can include bounding and decision logic, drafting communications, coordinating execution across functions, and guiding effectiveness checks and closure activities so you stay compliant and aligned internally.

Post-Recall Transformation

After the immediate crisis is contained, AlphaPath helps convert recall lessons into durable operational improvements. This service focuses on root cause analysis, CAPA strengthening, process redesign, and integration of recall learnings into your QMS, supplier controls, and product development practices to reduce the likelihood and impact of future events.

FDA Communication Coaching

AlphaPath prepares your leaders and subject matter experts for clear, consistent, and regulator-ready communication during and after recall events. Services can include message framing, review of submissions and updates, and practical coaching for difficult FDA discussions so your team shows up aligned, confident, and credible.

AlphaPath designs and facilitates realistic mock recalls to test your procedures, team readiness, and decision-making under pressure. These tabletop exercises surface bottlenecks and role confusion in a safe environment, then translate findings into targeted improvements, training updates, and playbook refinements.

Recall Simulation Workshops

Interim Recall Leadership

For organizations facing capacity gaps or an especially complex event, AlphaPath can step in as interim recall leader or program advisor. This support provides experienced recall decision-making, cross-functional coordination, and structured project management so your internal team can focus on technical and quality work while the process stays on track.