With our expertise we can advise on the best strategies for filing and assuring you have the necessary quality management system in place to maintain sustained cGMP compliance.

We help you avoid the common pitfalls and delays while bringing your product to the market faster, minimizing the time and costs involved, and maximizing your product revenues.

Whether your new product is a medical device, IVD, biologic, or a combination device, we have the resources and proven expertise through successfully submitting hundreds of Premarket Notifications (510k) and Investigational Device Exemptions (IDE). This means we help you obtain FDA 510(k) clearance or IDE approval efficiently and effectively. We focus helping you get your device to market on budget and on time. We also have the expertise to serve as an extension to your team to develop Premarket Approval (PMA) applications, and Technical Files and Design Dossiers for submission to Notified Bodies. And by the way, we can help you establish the appropriate reimbursement codes!

Some of our past regulation application clients are:
  • Medical device manufacturers or importers/exporters wishing to introduce a new medical device to the US market.
  • Specification developers that design a device and have it manufactured by another company for eventual sale in the US.
  • Companies that are proposing a significantly different design or different Intended use for a product that is already sold in the US.
  • Repackagers or relabelers of devices.
  • New inventors, doctors or small business owners entering the medical device ‘space’.

Marketing application submissions is a time consuming, detailed process. It is worth doing, but only if it is done right the first time. With our expertise on your side, you will get it done right the first time and you will save time, money, while having the peace of mind that your application is done correctly, and on time, on budget and cleared or approved the first time.

Our experts act as an interface between your company and the FDA, walking you through the process relieving the stress and details of this meticulous process. We also receive and respond to the FDA’s questions for you so you can get back to running your organization. We can also be of assistance in scheduling and attending inspections conducted by the FDA.

How it works

We suggest that you book a no-obligation consultation with us here to evaluate how we can help your organization or project with your application. In addition to Regulatory Applications, we are also experts in Risk Management and Quality Management System Integration and Implementation (the ongoing process to keep your FDA approved organization running smooth) and Remediation (when companies get in distress with the FDA for being out-of-compliance).

Our process includes:
  •  A GAP analysis
  • Regulatory document preparation and submission (e.g. 510(k), IDE, PMA, Technical File, or Design Dossier), as appropriate
  • Establishment of Design Controls, if needed
  • Risk Management and Quality Management System Integration and Implementation (if needed)including support for the supplier management processes, if needed
  • Avoiding pitfalls, misapplication, and unmitigated risks
  • Business development, as appropriate
  • Reimbursement Code Determination, if needed

To find out how we can help your business, contact us today for a free, no-obligation consultation.