FDA Regulatory Compliance Consulting

If knowledge is half the battle; the other half is preparation. The companies who are successful in managing inspections have trained, practiced and prepared for them.

Some of the key needs in preparing for the next FDA inspection include:

• Developing an FDA preparation and inspection management strategy.
• Reviewing objective evidence to ensure the effectiveness of actions taken to address any previous inspection findings.
• Interacting mock FDA interviews with subject matter experts and key personnel to help them practice effective communication and presentation skills.
• Performing mock inspections to stress-test personnel and the quality management system to evaluate the ability to deliver documents, records and information in an effective and timely manner.
• Preparing reports and strategies to address any gaps found during the inspection preparation activities.

Following an FDA inspection, the need to promptly prepare a compelling response to address an FDA 483 or Warning Letter is crucial. At QualityHub, we have former FDA Office of Compliance directors, associate directors, branch chiefs and investigators who can assist you in crafting your response to minimize further enforcement action.

Often situations arise where the best course of action is an in-person meeting with the FDA and/or other regulatory authorities. QualityHub will partner with your leadership team as FDA regulatory compliance consulting experts to help you prepare for your meeting, attend your meeting with the regulators and debrief with the leadership team afterward.

Our extensive experience with the FDA and similar regulatory authorities can be leveraged to help you deliver the right message.

We provide post-inspection support in the following areas:

• Strategic planning for regulatory agency interaction
• Communicating with regulatory agencies
• Supporting and communicating for 483s, recalls, Warning Letters and Consent Decrees
• Assisting with FDA negotiations and appeals
• Verifying client’s progress to FDA and regulatory bodies
• FDA liaison for international and domestic clients
• Preparing FDA meeting requests and requisite briefing packages
• Delivery and preparation of presentations to FDA and/or other regulatory bodies
• Performing onsite regulatory assistance and training related to regulatory interactions
• Guiding the latest regulatory issues and requirements

The occasional need to perform a recall or field corrective action (FCA) is not uncommon in the medical device, pharmaceutical and biologics industries. Determining when to perform a recall/FCA, establishing the strategy and then executing the action with proper objective evidence can be challenging.

QualityHub can assist your organization in managing recalls/FCAs by:

• Preparing procedures for compliance with applicable regulations for correction and removal
• Assisting in preparing or reviewing Health Hazard Evaluations to help document the scope of patient/user risk
• Drafting recall letters
• Coordinating communication with both customers and the regulatory authorities
• Aiding in verifying the effectiveness of actions taken

With an excellent reputation with industry regulators and a strong combination of former FDA officials and industry experts, we have a successful track record of assisting companies in writing effective, well-received responses to FDA-483s, Warning Letters, and Consent Decrees.

QualityHub’s strategic compliance plans, often developed in response to inspection, are designed to provide a clear roadmap for establishing the foundation for sustained compliance. We have resources to assist your company in managing corrective and preventive actions undertaken in response to FDA enforcement actions, including the development of the appropriate objective evidence for submission to the FDA or for review in the next inspection.

Because of the breadth and depth of our resources, you have the advantage of being able to use a single source for your FDA regulatory compliance consulting and temporary staffing needs. This helps reduce or eliminate the risks, conflicts, confusion, rework and increased costs that are known to happen when multiple consulting organizations attempt to work on the same project.

QualityHub can also assist with:

• Analyzing current and past FDA-483s, internal, and external audits
• Developing and executing corrective action (compliance) plans that will be effective from a quality and regulatory perspective but will also be consistent with your unique business needs
• Giving periodic updates to an FDA-483 or Warning Letter
• Providing independent third-party reviews of responses prepared by your company for submission
• Performing quality and/or certification audits when requested under an enforcement action