Our Comprehensive Regulatory & Compliance Service
Jessica Mu Consulting, LLC offers a wide spectrum of expert regulatory and compliance services designed to guide medical device and pharmaceutical manufacturers through their most critical challenges. My boutique model ensures you receive direct, personalized attention and strategies aligned with your specific needs; approaches are built on years of FDA insight, ensuring pragmatic solutions to achieve compliance.
-
Compliance Assessment
Conduct thorough evaluations of your current quality systems and regulatory practices to identify gaps and areas of risk. Let our assessments provide clear, actionable insights, transforming findings into focused, risk-based strategies that strengthen your compliance posture.
-
Mock FDA Inspections & Coaching
Prepare your team with confidence through realistic, on-site, FDA-style inspections. We provide coaching, mock interviews, document reviews and on-the-spot guidance to help your personnel be prepare to engage investigators with confidence.
-
FDA Inspection support
During actual FDA inspection, we provide calm, expert, in-person back-room support. Our immediate guidance helps manage document requests, interpret investigator questions, and facilitate effective communication, minimizing disruptions and ensuring your responses are strategic and compliant.
-
FDA 483 Response Strategy
A robust response to an FDA Form 483 is critical. We help with tailored, evidenced based corrective action plans and clear narratives that directly address FDA’s observations. Our strategies focus on mitigating regulatory and product risks and preventing further escalation.
-
Warning Letter | Untitled Letter Responses
Receiving a Warning Letter or Untitled Letter signals serious regulatory concerns. We help strategize comprehensive and clear responses that directly address the core of FDA’s concerns. Our approach targets immediate and systemic remediation actions commensurate with product and regulatory risks.
-
Regulatory Meeting Preparation & Guidance
Regulatory meetings, particularly those preceding potential judicial actions like permanent injunctions, require meticulous preparation. We provide strategic guidance to prepare your team for these high-stakes discussions, ensuring your responses are well-aligned with product and regulatory risks, and effectively communicate your commitment to compliance.
-
FDA Recall Guidance
Navigating an FDA recall is complex and time-sensitive. We support the development of your recall strategy, from initiation to termination, including coaching on effective communication with the FDA.
-
Dietary Supplement Regulatory Support
The regulatory landscape for dietary supplements can be challenging. Please contact us to explore how our tailored consulting services may be right for you.
