QPC’s regulatory monitoring service is a management solution, focused on identifying, tracking and analyzing critical policy and regulatory developments occurring within your business with goals to ensure regulatory compliance and further eliminate business administrative or criminal sanction risks.
Whether your new product is a drug, a biologic, a device or even a combination, we have the resources and proven expertise to develop an appropriate monitoring strategy to fit your business goals.
We can help your organization take products successfully through difficult, expensive and lengthy product development processes, including clinical development, submission, approval and training through our senior regulatory professionals, experienced in pharmaceutical, diagnostic, device and biotechnology industries.
Our solution is specifically tailored to your business needs through calculated steps that assess your current regulatory environment, relevant guidelines, ongoing FDA and/or international medical device initiatives and critical influencers on your path to regulatory approval, with goals to facilitate a timely, competitive, and successful product clearance or approval with continued sustainability.
Our process is designed to carefully rationalize your requirements — often beyond what is available in published materials, directives, and FDA guidance documents — including, device descriptions and specifications, intended clinical applications, labeling claims, available test data, and literature references. We then review information about possible similar, predicate devices to yours, along with standard methods, procedures and/or practices, FDA submission guidance documents, and other medical device regulations and policies that may apply to your product.
We can provide comprehensive services from our facility or onsite in order to meet your project needs with experts to guide you throughout all phases of the monitoring solution and necessary documentation. Our team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
We will define a strategy that will move your device along the appropriate pathway more easily and reduce the cost and time to bring your innovation from the bench to the bedside – and meet your ultimate goal of bringing safe and effective medical technology where it is needed, to the patient.
To find out how we can help your business, contact us today for a free, no-obligation consultation.