FDA (QMS/GMP) Regulatory Guidance & Support

Confirm your QMS & GMP Processes are clear, easy to understand and complete!

“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, Clinical Software 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
    • Process established to demonstrate substantial equivalence of your product to a predicate device on the market
  • Premarket Approval (PMA) – 21 CFR Part 814
    • Process established to ensure safety and effectiveness of your medical device
    • Electronic Records; Electronic Signature Certification – 21 CFR Part 11
  • Computer systems validation
    • In support of 21 CFR part 11 and GAMP 5 (a risk based approach to computerized GxP systems)
  • Quality System Regulation (QA) – 21 CFR Part 820
    • Harmonization of International Standards
      • ISO 13485 requirements for a Quality Management System
      • ISO 14971 a risk approach to design, development and manufacturing activities
      • IEC 62304 lifecycle requirements for the development of medical software
      • IEC 62366 application of usability engineering requirements for the development of medical devices (software/hardware)
  • Good Manufacturing Practices (GMP) – 21 CFR Part 26
  • US and International Harmonization
  • Optimizing Processes through Continuous Improvement
  • Process
    • GAP Analysis
    • Improvement Path
    • Implementation of Corrective Actions
    • Confirmation of Desired Goals

Whether it’s a 510(k) Clearance, Good Manufacturing Practices (GMP) determination, Quality Management System (QMS) completeness, or a Biologic License Application (BLA) Submittal – it’s one of many hurdles to get over before your medical device/application/drug can be brought to market.

Our team can perform a Gap Analysis to ensure your QMS processes are clear, easy to understand and complete.

Dealing with an FDA Submittal? It’s important to get this right because it 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.

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 required documentation
  • Incomplete or not-easy-to-understand QMS processes
  • Major disconnects between Manufacturing processes and R&D

One of our biotech clients wanted to add an Instrument to their GMP workflow, but they didn’t have the knowledge or resources necessary to accomplish the task.

Our process quality expert recommended a gap analysis, which enabled us to review all their QMS (R&D/Manufacturing) procedures, documentation and processes. Afterwards, he worked with the client to produce a thorough risk-based implementation plan, with items listed by order of priority.

Our team went to work, implementing all the corrective actions, and the client was able to successfully add the instrument to their GMP workflow; additionally, all of their processes & procedures were updated for compliance with FDA and International Standards.

Now they have everything in place so, if an FDA audit should occur they’ll be able to sail through with flying colors.


If you’re experiencing these quality challenges – we know you’re under a lot of stress.

Here’s the good news – our experts have been helping teams address and systematically resolve these issues for decades – we can help you overcome your challenges and transition into a highly productive organization, capable of delivering quality products (on time) on a consistent basis.

Reach out today and request a Free Consultation. It’s a straight forward process, and we think you’ll agree – the earlier you start, the earlier you’re on the path to a highly improved process with a newly energized team – armed for success!

Ask Judy to schedule a Free Consultation – today!

Contact Judy Cirilos: judy.cirilos@advantu.com

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