FDA QMS/GMP Regulatory Guidance & Support

Confirm your QMS/GMP Processes are 100% reliable, to ensure a Safe, Audit Proof Quality Mgmt System across the board…

“I’m very happy with the level of commitment to the project, adaptability and willingness to take on additional tasks as they arise and guide us through the submittal process.”

Project Manager, Medical Application Project: 

Advantu’s FDA Process Experts are experienced with the following:

  • Establishment Registration – 21 CFR Part 807
  • Medical Device Listing – 21 CFR Part 807
  • Premarket Notification 510(k) – 21 CFR Part 807 Subpart E
  • Premarket Approval (PMA) – 21 CFR Part 814
  • Electronic Records; Electronic Signature Certification – 21 CFR Part 11
  • Quality System Regulation (QA) – 21 CFR Part 820
  • Good Manufacturing Practices (GMP) – 21 CFR Part 26
  • US and International Harmonization
  • Optimizing Processes through Continuous Improvement
  • Process
    • Assessment
    • GAP Analysis
    • Improvement Path
    • Implementation

Whether it’s a 510(k) Clearance, Good Manufacturing Processes (GMP) determination, Electronic Health Record (EHR) reliability, or a Biologic License Application (BLA) Submittal – it’s one of many hurdles to get over before your medical device/application can be brought to market.

It’s important to get this right because the FDA Submittal Process can be excruciatingly time consuming if you don’t – so we want you to be aware of the common mistakes companies make, in order to avoid them.

Below are the typical challenges teams face:

  • Lack of process knowledge
  • Inconsistency with documentation
  • Not understanding what needs to be submitted
  • Need to demonstrate equivalence with predicates
  • Not providing all of the expected testing
  • Lack of knowledge regarding differences between verification and validation
  • Underestimating risk management requirements
  • Incorrect formatting of the submission

One of our biotech clients ran into similar issues during their Submittal – it had become 2 steps forward and 5 steps backwards…getting worse over several quarters until we were brought in.

We were able to help them overcome these challenges in order to achieve a successful completion of the process.

To avoid the common mistakes listed above, let Advantu’s experts help you put together a well-written submission, so you can successfully complete the process within a realistic time frame and meet your product release goals. 

Additionally, with a proper analysis of your QMS/GMP Processes, we can reveal the blind spots which will be discovered during an FDA Audit or by your clients after a ‘rushed’ product release – let our team help insure your company against future calamities. Don’t be caught by patient health record breaches or product recalls, and all the bad press that’s associated with them; find the hidden gaps in your processes today, so you can be confident in tomorrow.

Check out our helpful Industry information:

Here’s our latest FDA Podcast

Recent FDA submittal blog


Call today & ask how we can support your FDA Process – let’s get this turned around in your favor!  858.275.2106