Don’t let that FDA Warning Letter throw you off – we can help. After 13 years of experience working with medical device and pharmaceutical companies in regulatory distress, we can get you back on track quickly.
Ensuring compliance is only half the battle. We recognize the other half of the battle; leveraging Quality Management System (QMS) performance as a mission-critical management tool to help build your business is the other half of the battle. Our goal is to help you use the simple but effective Plan, Do, Check, Act remediation model to drive efficient and effective remediation.
Let our 13 years of experience in navigating troubled regulatory landscapes help you to eliminate your organization’s regulatory distress. We have the Sr. Consultants, Team Leaders, Subject Matter Experts (SME), Project Managers, and Support Staff necessary to drive an effective and efficient remediation project.
How it works
Plan: We help you determine the best approach(s) to establishing the scope of remediation necessary to drive your organization out of regulatory distress, and to keep the organization from facing regulatory problems in the future.
Do: We not only provide guidance on how to execute Quality Management System Remediation, but we participate in the execution of the remediation activities. Please note that we do not do it all for you, because this would not help the organization in the long run, and it would not be a cost effective solution.
Check: Milestones and Planned Systemic Reviews are essential to assuring that the remediation activity does not run amuck. We use Project Managers to help the organization reach miles stones and check performance.
Act: Tactical adjustments will be frequently required; it is just part of the process. Remediation is difficult, and so we must all be prepared to act as soon as a deficiency in execution is identified. We are experts at this, and we believe this is one of the significant differences between QPC Services and most of our competitors.
In addition to the Plan/Do/Check/Act core model, we tie our success to the success of our clients. We establish meaningful milestones with measurable requirements. We prize efficiency as well as effectiveness, and we place a significant portion of our billing on bonuses for milestone completion with quality deliverables that are on time or sooner. In this way, be believe, we allow our clients to pay for actual performance, not promised performance. We become a part of your team, and we stay ‘in the boat” with you throughout the remediation journey.
Some of our past remediation clients are:
- Medium sized medical device manufacturers facing significant quality and regulatory issues for the first time in their company history.
- Small medical device manufacturers who were at risk of going out of businesses due to quality/regulatory problems.
- Foreign manufacturers who were on import detention. Specification developers that design a device and have it manufactured by another company.
We do not suggest just ‘checking some of the boxes’ in a way that results in band aid fixes, and hoping that the FDA doesn’t find out that you are still not compliant. Remediation is not a fun process to go through and chances are it’s only a matter of time before your company faces a Warning Letter or other regulatory action that can cost you millions in lost revenue. We are built to help you in that difficult time. We believe our remediation approach is both effective and efficient.
We also offer preventative services to help your company grow and avoid regulatory distress. These services are: New Product Applications (done right on time and on budget), and Risk Management and Quality Management System Integration and Implementation (managing the risks so your business runs smoothly and compliant).
What makes us different
QPC will provide you a dedicated remediation expert committed to your organization who walks you through the entire process. Additionally, we also build a business improvement roadmap that will help drive you from the remediation situation, through the changes you need to make to becoming an even more successful and profitable company. Additionally, we’ll define your current state QMS metrics and capture data within your organization to help uncover hidden non-conformances, further enable data-driven decision-making and foster continual improvement.
Additionally, the QPC Remediation process will equip you with the powerful reports and a plan of action you’ll need to drive cross-functional department adjustments in working practices and accelerate end-to-end continual improvement across your organization.
If you have received a Warning Letter the time to act is now. Contact us today for a free, no-obligation consultation.
Our brand promise
In everything we do we bring relief and results to our customers so they can get back to business knowing their product applications, risk management and quality management system integration, and cGMP compliance are being taken care of by the best people possible.