The top 10 life science quality assurance consultants to work with in 2024


    Life sciences consulting, particularly quality assurance consulting, can offer a transformational kickstart for your life science company.

    Securing a life science consulting expert with deep, industry-specific quality experience is a great way to streamline even your most complicated go-to-market projects, helping you jump challenging regulatory hurdles with supportive expertise at your side.

    Is your medical device company facing an uphill battle with the FDA?

    Struggling to pass an audit and get ISO-certified quickly?

    The best life sciences consulting services will lift your QMS to new levels, helping you achieve compliance, obtain certification and take safe, effective products to market.

    To help you find the support you need, we've assembled a crack team of the top 10 quality assurance consultants you can call on today - and awarded them our Industry Leader 2024 badge to prove their know-how!




    Table of Contents

    1. The top 10 life sciences consulting experts for 2024
      1. Dave Schoneker 🇺🇸
      2. Stephanie Rallis-Daw  🇺🇸
      3. Lee Walsh  🇦🇺
      4. Rob Packard  🇺🇸
      5. Jack Sinclair 🇬🇧
      6. Peter Sebelius 🇸🇪
      7. Carlos Galamba 🇪🇸
      8. Pierre Servan 🇺🇸
      9. Kate Creegan-Biltcliffe 🇺🇸
      10. Neasa Greene 🇮🇪

    2. Picking the right quality assurance consulting services for you


    The top 10 life sciences consulting experts for 2024


    There are several reasons for modern life science companies to turn to quality management consulting.

    Life sciences consulting experts are commonly called in to address compliance challenges, validate projects, or complete applications for device and drug approval.

    Medical device, pharmaceutical and biotech consulting experts can even assist with creating a regulatory strategy, implementing a quality management system or even providing long-term expert support.


    MORE READING: Quality management consulting: how to evaluate and choose the best consultant


    Every quality assurance consultant included in this list has extensive experience working with regulated firms in the life sciences industry. However, they offer slightly varying specialties and expertise.

    Remember: you can also fast-track your way to life science compliance and a quality-driven culture with careful investment in the right digital tools, such as Qualio’s cloud-based electronic quality management system (eQMS)!



    1. Dave Schoneker 🇺🇸


    Dave Schoneker


    For pharmaceutical consulting expertise, look no further than Dave Schoneker and his Black Diamond Regulatory Consulting operation.

    From targeted market advice to GMP audit assessments, dossier construction and quality training, Dave has a wealth of quality assurance consulting expertise to offer.

    He brings over 40 years of pharmaceutical excipient and food additive experience to the table, and counts major pharmaceutical manufacturers among his client base.


    Contact Dave



    2. Stephanie Rallis-Daw 🇺🇸


    Stephanie Rallis medical device consultant


    Stephanie established California-based Rallis Consulting in 2015 to offer high-quality consultancy services to medical device companies.

    From a document control coordinator and quality engineer to a string of director and senior director positions, Stephanie has worked her way to the top of the medical device quality world and can share a wealth of hands-on experience with clients.

    Alongside her consultancy work, Stephanie is also a lead auditor for notified body DEKRA and an advisory board member of UCR's Design Thinking Executive Program.

    Contact Stephanie for help with your quality and compliance activity, including:

    • QMS building
    • Risk management
    • Verification and validation
    • Auditing
    • Statistical analysis

    And more!


    Contact Stephanie



    3. Lee Walsh 🇦🇺


    Lee Walsh medical device consultant


    Lee is the founder and managing director of the wonderfully named Platypus MedTech Consulting.

    From his base in Canberra, Australia, Lee and his team of 3 medical device experts offer targeted support for medical device companies who need:

    • Help charting a regulatory pathway to market
    • Help constructing a quality and risk management system compliant with ISO 13485, ISO 14971 and IEC 62304
    • Support building and submitting regulatory documents for market access
    • Help managing post-market activity and regulatory investigation


    Lee is particularly skilled in digital and SaMD products, including cybersecurity management, and has a track record of supporting clients both in and outside Australia.


    Contact Lee



    MORE READING: The pros and cons of medical device consulting


    4. Rob Packard 🇺🇸


    Rob Packard life science quality consultant


    Trying to bring a medical device to market?

    Rob Packard and his Medical Device Academy team are here to help.

    Rob specializes in guiding clients through key medical device regulatory submissions like 510(k)s and 513(g)s, as well as supporting ISO 13485 certifications and CE mark technical file builds.

    For a fun, personable approach that gets results, look no further than Rob.


    Contact Rob



    5. Jack Sinclair 🇬🇧


    Jack Sinclair quality consulting


    Jack is Business Manager at London-based Apotech Consulting, and specializes in medical devices and IVDs for his clients.

    Jack is a great choice to act as your UK Responsible Person (UKRP) if you're entering the British market - and he and his team can also help your activity on the continent with EU MDR and IVDR support, too.

    Contact Jack and Apotech for:

    • British and European medical device market entry support
    • FDA submissions
    • Building and maintaining an ISO 13485 QMS
    • Authoring of critical documents like CEPs, CERs, PERs, PMCFs and other technical file needs
    • Launching a regulatory strategy


    Contact Jack



    6. Peter Sebelius 🇸🇪


    Peter Sebelius quality assurance consultant


    Peter is a legend of the Scandinavian medical device industry, and for good reason.

    After a string of leadership positions at medical device manufacturers across Sweden and Denmark, Peter founded his Medical Device HQ consultancy business in 2008.

    Peter's USP? A calm, human and no-nonsense approach to the complex demands of medical device quality assurance consulting. Peter and his team host a popular series of online and classroom courses to turn customers into experts in:

    • Design controls
    • Device risk management
    • Quality management
    • Project management
    • Software as medical device (SaMD) development


    And more.

    Watch him in action with us here!




    Contact Peter



    7. Carlos Galamba 🇪🇸


    Carlos Galamba life sciences consulting


    Need a highly specialized in vitro medical device expert by your side?

    Carlos lives and breathes IVD expertise, and for good reason.

    After 6 years at BSI in a series of IVD roles, he rose to IVD Director and eventually VP of MedTech Intelligence & Innovation at RQM+, during which time he also served as an external expert for the European Commission.

    Carlos now runs Barcelona-based MDx CRO, helping clients get to grips with the EU IVDR and the demands of modern CE marking.

    Reach out to Carlos for help with your IVD clinical research and regulatory challenges.


    Contact Carlos


    8. Pierre Servan 🇺🇸


    Pierre Servan life science consulktant


    Pierre is Principal Consultant and the owner of Factor Quality, a California-based quality assurance consulting center.

    Pierre's superpower?

    Guiding clients to airtight, long-term compliance with specific management system standards, and particularly ISO.

    Reach out to him if you want help meeting the requirements of:

    • ISO 9001
    • ISO 13485
    • ISO 17025
    • ISO 14001
    • ISO 45001
    • AS 9100
    • AS 9110
    • AS 9120
    • IATF 16949

    And more!


    Contact Pierre


    9. Kate Creegan-Biltcliffe 🇺🇸


    Kate Creegan-Biltcliffe quality assurance consulting


    To lift your quality management to new levels with software, look no further than Kate and her Massachusetts-based 11 Compliance Consulting.

    Kate specializes on helping her clients implement eQMS platforms like Qualio, as well as LMS and EDMS platforms.

    Best of all, her team take on the hard work for you in key areas like:

    • Computerized system validation
    • Training your end users
    • Setting up integrations
    • Administrating your system
    • Overall software project management


    Contact Kate


    10. Neasa Greene 🇮🇪


    Neasa Greene life science quality consulting


    Our final quality assurance consultant expert hails, like our own CEO, from the Emerald Isle.

    And like Qualio, Neasa is passionate about guiding medical device start-ups and scale-ups to quality success.

    Based in Dublin with her own Neasa Greene Consulting, Neasa works hard to break down the complexity of modern medical device quality demands into actionable steps toward long-term success.

    And she operates on both sides of the Atlantic, too, supporting clients with both ISO 13485 and 21 CFR 820 QMS design, development and launch. As a certified lead auditor, Neasa also specializes in deep-dive examinations of client operations, as well as building KPI-based continuous improvement pathways, supporting training, and even strengthening your post-market surveillance activity.

    For an all-round medical device expert with bags of experience and a friendly approach, Neasa makes the perfect candidate.


    Contact Neasa



    Picking the right life science quality assurance consultant for you


    The right quality assurance consultant can help your organization bring safe and effective devices and drugs to market by creating a regulatory strategy, supporting clinical trials, and helping your organization achieve ISO, FDA or EU approval.

    Understanding the strengths and specialties of each quality assurance consulting option can be a helpful way to narrow your search: evaluate a prospective consultant’s experience based on their record of success, their cost, and their cultural fit. And make sure you ask for life sciences consulting references and case studies to verify experience working with similarly sized clients.

    Feel free to reach out to our team for a recommendation here!