About me, Jessica Mu:

With 28 years of experience in the life sciences quality and compliance space, including over 20 years at the U.S. Food and Drug Administration in Investigations, Compliance Officer, and Compliance Director roles, and nearly a decade in industry, I’ve navigated the medical device product lifecycle from both sides of the fence.

In April 2025, I retired from the FDA and launched Jessica Mu Consulting, LLC. As a boutique consulting firm, my goal is delivering highly personalized and strategic guidance. I believe that effective compliance is founded not just on meeting regulations, but on establishing sustainable, systemic Quality Systems that foster a culture of robust quality and support innovation.

This focused approach ensures you work directly with me, leveraging my inside knowledge to provide pragmatic, actionable strategies tailored precisely to your unique needs. While I maintain strong connections within the industry to strategically collaborate on larger, specialized projects when appropriate, my commitment is always to provide direct, high-level expertise with public safety at the forefront.

Comprehensive Regulatory & Compliance Service

Jessica Mu Consulting, LLC offers a wide spectrum of expert regulatory and compliance services designed to guide medical device and pharmaceutical manufacturers through their most critical challenges. My boutique model ensures you receive direct, personalized attention and strategies aligned with your specific needs; approaches are built on years of FDA insight, ensuring pragmatic solutions to achieve compliance.

• Compliance Assessment
• Mock FDA Inspections & Coaching
• FDA Inspection Support
• FDA 483 Response Strategy
• Warning Letter | Untitled Letter Responses
• Regulatory Meeting Preparation & Guidance
• FDA Recall Guidance

For additional details, please visit www.jmuconsulting.com

NPDK Bioconsulting is a Regulatory CMC consulting and regulatory writing firm specializing in the development, compliance, and FDA regulatory support for a broad range of biotechnology and biopharmaceutical products, including cell and gene therapies (CAR-NK, CAR-T, viral vector-based), monoclonal antibodies, antibody-drug conjugates (ADCs), therapeutic proteins, vaccines, and any new therapeutic modalities. We also offer intellectual property services by supporting US patent application filing and prosecution related to biotechnology innovations.

Dedicated to assisting small and mid-size international biotechnology companies, NPDK Bioconsulting brings deep expertise across R&D, GMP manufacturing, quality assurance (QA), and global regulatory requirements. We help clients initiate early engagement with the US FDA, efficiently navigating the product and process development CMC landscape, and aligning development programs with current FDA and EMA regulatory frameworks.

To learn more about NPDK Bioconsulting services please visit: https://npdkbio.com/

Our services include strategic CMC regulatory consultation, regulatory authoring, and submissions for Pre-IND (PIND), IND/IMPD, and BLA/MAA applications. We provide regulatory guidance and author briefing packages for FDA and EMA meetings, ensuring alignment with evolving global standards. Meet our Regulatory Affairs team: Natalia Pripuzova, PhD

Additionally, we offer expert assistance in intellectual property protection through U.S. patent strategy and prosecution. Meet our IP Counselling team: Dmitry Kryndushkin, PhD

If you require highly qualified and affordable Regulatory Affairs CMC or Intellectual Property Law services, please contact us to discuss your needs: natalia.pripuzova@npdkbio.com

MDSS: Your trusted partner for In-Country Representation & comprehensive regulatory support!

For over 30 years, MDSS (mdssar.com) has been a trusted Authorized Representative specializing in Regulatory Affairs for Medical and In Vitro Diagnostics devices.

We offer comprehensive In-Country Representation across the EU, UK, Switzerland, USA, and Australia, designed to minimize complexity, save time, and reduce costs, allowing you to focus on your core business, including innovation.

MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).

In-Country Representation Services

• European Authorized Representative (EC REP)
• EU Representative – GPSR
• EU Representative – GDPR
• Legal Representative for the Sponsor
• National Registration
• Free Sales Certificate
• Importer of products
• U.S. Agent to the FDA
• UK Responsible Person (UKRP)
• Swiss Authorized Representative (CH-REP)
• Australian TGA Sponsor

Other Services

• Regulatory Consulting
• Cosmetics (Safety and legal compliance for cosmetic products)

Email: deborah@madsenqrc.com

Phone/text: 909-720-9071

Madsen QRC provides quality system and regulatory compliance consulting to the medical device device industry.

Areas of expertise include:

• Providing advice, assistance and guidance to the medical device industry in the areas of quality systems, ISO 13485, FDA QMSR, IEC 62304, and MDSAP implementation and compliance.
• Internal and supplier audits in accordance with ISO 13485, FDA QMSR, MDR, MDSAP, Korea MDA, UK Regulation for Medical Devices.
• Assistance designing to meet applicable product safety standards and regulatory requirements.
• Auditor and quality system training.
• Perform comprehensive design and risk management reviews.
• Provide EMC and product testing protocol development and assistance with obtaining safety certifications (IEC 60601-1, IEC 61010-1 series of standards; UL, TUV, Nemko, Intertek).
• Implement and maintain quality management systems.
• Lead management review meetings.

Deborah Madsen has over 35 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical devices.  Deborah has held roles as NB auditor, product safety engineer, Director of Quality and Regulatory for medical device and IVD start-ups.  Deborah holds a degree in Electrical Engineering, and is a Registered Professional Engineer in the state of California.