Inspection Readiness
Inspections are not a threat to your company — they are an opportunity to ensure quality, safety and consistency in your clinical research and manufacturing processes. FDA, EMA and MHRA inspection readiness solutions enable you to identify and bridge compliance gaps. At FDA Quality and Regulatory Consultants (FDAQRC), we help pharmaceutical, biotech and medical device companies prepare, manage and respond to these inspections.
Our Proactive, Active and Reactive Support
FDAQRC’s FDA, MHRA and EMA inspection readiness services support companies throughout the life cycle of an inspection, from mock audits to 483 responses. While it is beneficial for any company to take a proactive approach to inspection readiness, we can also help companies navigate an upcoming inspection. Explore our inspection readiness solutions:
Proactive Steps: Prepare for the Inspection
Ideally, inspection readiness should be a continuous state, not a rushed project before an FDA investigator visits your facility. Planning ahead gives you more time to demonstrate your commitment to quality. Whether you have a for-cause inspection coming up soon or would like to achieve this continuous state of readiness, we help you prepare with:
- Mock inspections and gap assessments: Our experts simulate real inspections and audits as a diagnostic tool to identify vulnerabilities in a controlled environment. We find compliance gaps before inspectors do.
- Document reviews: We will review critical documentation such as Trial Master Files (TMFs), Corrective and Preventive Actions (CAPA) records, equipment logs, training files and other records to maintain integrity, accuracy and transparency.
- Staff training: Our inspection readiness solutions include group and one-on-one training to guide your staff on communicating with inspectors, fulfilling requests during the inspection and managing interview stress.
- Site preparation: We also offer site mock inspections, where we conduct on-site drills to help you ensure your facility and team are ready for the inspection.
Active Support: During the Inspection
The team at FDAQRC is your partner during the inspection, providing real-time on-site or remote assistance. Our services include expert support while the inspection takes place, helping you and your staff respond to inquiries. Since our team consists of former FDA Investigators and Compliance Officers, we know how to facilitate inspector requests to streamline the process and demonstrate your commitment to compliance and quality.
Reactive Solutions: Response to Inspection Results
After the inspection, we provide specialized guidance on responding to inspectional observations from an FDA Form 483 that notifies your company of potential issues. We support you through this reactive phase, helping you craft a 483 response that acknowledges the FDA’s observations and outlines your immediate corrective plans, with the aim of preventing further action. Our offerings also include remediation to ensure long-term compliance and quality after the inspection.
Why Trust FDAQRC for Inspection Readiness?
FDAQRC has a global reach and a network of over 500 consultants. We also have a full-time team of 20 experienced consultants in multiple countries. In addition to having former FDA personnel on our team, we have credentialed healthcare professionals, ensuring your pharmaceutical, biotech or medical device company receives the expert guidance it needs.
Turn Your Next Inspection Into an Opportunity With FDAQRC
Maximize compliance and consistent quality across every department with our EMA, MHRA and FDA inspection readiness services. Contact us today and one of our professionals will set up a one-on-one consultation to start the process.
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