FDA Regulatory Guidance & QMS Support

Confirm your QMS for R&D, Manufacturing & Supplier Quality is 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 QMS tasks as they arise and guide us through the submittal process.”

Project Manager, FDA Submittal Project

Advantu’s FDA Process Experts are experienced helping Quality Teams Harmonize their QMS across their organization.  This yields shorter Submittal cycles, smoother FDA Audits and Product Releases with No Surprises.

  • Establishment Registration – 21 CFR Part 807
  • Medical Device Listing – 21 CFR Part 807
  • European Union – New Regulation(s) Compliance
    • Medical Device Regulation (MDR) 2017/745
    • In Vitro Diagnostic Regulation (IVDR) 2017/746
  • 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 (CSV)
    • In support of 21 CFR part 11 (Electronic Records: Electronic Signatures) and GAMP 5 (a risk based approach to Compliant GxP Computerized Systems)
    • Including intended use validation (IUV) of non-product software applications
  • Quality System Regulation (QSR) – 21 CFR Part 820 / ISO 13485:2016
    • Harmonization of International Standards
      • ISO 13485 Quality Management System requirements
      • ISO 14971 Risk Management for Medical Devices, a risk approach to design, development and manufacturing activities
      • IEC 62304 Medical device software – Software lifecycle processes 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)excessive capa's
    • Contract Manufacturing Organization (CMO/CDMO)
      • Vendor Selection & Management
        • Do their capabilities meet all your needs
      • Vendor Agreements
        • QA Functions clearly defined before project starts
        • Develop a technology transfer package
      • Vendor Communications
        • Total transparency & clarity is essential
      • Vendor cGMP Manufacturing Capabilities
      • Intellectual Property Protection
      • Planning for Surprises (create predefined responses to most common hurdles)
        • Mutually agreed upon contingency plan
        • Communications with FDA (clearly defined responses from client, vendor)
  • Supplier Quality / Supplier Management Systems
    • Purchasing & Supplier Quality Agreements
      • Supplier Evaluation
      • Supplier Monitoring (auditing)
      • Supplier Documentation
      • Supplier Communications
      • Supplier Quality Agreements
      • Supplier Quality Certification
  • US and International Harmonization
  • Optimizing Processes through Continuous Improvement
  • FDA Communications & Interactions 
    • Warning Letters
    •  Recalls
      • Class I
      • Class II
      • Class III
    • Consent Decree
    • Successful Audit Prep

Our Solution Process

  • GAP Analysis
  • Improvement Path Report
  • Implementation of Corrective Actions
  • Confirmation of Desired Goals Successfully Achieved
fda cleared vs fda approved

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

Our team can perform a Gap Analysis to identify and recommend QMS Process improvement areas, prioritize the improvement areas and develop short term, intermediate term and long term plan to ensure your QMS processes are clear, easy to understand and address “Common Sense Compliance”.

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.

device master record

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.

QMS process improvement

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!

Reach out today!