Regulatory Strategy

Without strategy, execution is aimless. Without execution, strategy is useless.


 

Our experience working with FDA-483s, Warning Letters & Consent Decrees can help your leadership team create and execute the plans to overcome your company’s challenges. Our auditing expertise can help determine how widespread and how severe the gaps may be.

But finding your gaps is just the beginning. Our consulting expertise can help accomplish the work needed to bring your organization into compliance. We can provide the needed Project (Strategic) Leads, Project Managers and Subject Matter Experts who can help guide, coach and move the projects along. For more tactical work, our Associate Consultants can help execute on quality system deliverables and documents. Our Interim Professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing the FDA-483s, Warning Letters, and Consent Decrees.

 


 

 

Regulatory Agency Communication & Interaction

Following a FDA Inspection, the need to promptly prepare a compelling response to FDA is crucial. At QualityHub we have former Office of Compliance Directors, Associate Directors, Branch Chiefs and other ex-FDA personnel with first-hand experience in crafting and reviewing the adequacy of responses.

 

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FDA-483 & Warning Letter Responses

With a strong combination of former FDA officials and industry experts, we have a successful track record of assisting companies in writing responses and updates to FDA for 483s, Warning Letters, & Consent Decrees. If you are facing one of these scenarios, QualityHub can provide you with the proper guidance and support to prepare an effective response, and start the process of establishing the foundation for sustained compliance.

 

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FDA Inspection Preparation, Coaching & Management

Knowledge is half the battle; the other half is preparing and training for the day when you will need to be efficient and successful during an inspection.

 

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Independent Review of Planned FDA Responses

QualityHub understands the impact a FDA-483 or Warning Letter can have on your organization, and the pressures that arise when embarking down the path of Quality and Compliance Remediation. We have the experience to help you resume “business-as-usual” and at the same time address your urgent compliance needs.

 

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