Practical GMP and ISO Consulting for Pharmaceutical, Medical Device and Clinical Biotech Companies
Growing fast, but still figuring out GMP, ISO and regulatory compliance?
From GMP licensing and ISO accreditation, greenfield facilities, CMC and product development support, through to compliance, QMS/PQS, audits, training and business software transformation — right-sized for where you are, without the over-engineering.
Not sure where you stand? Complete our 3-minute, industry-specific scorecards to see where your gaps are.
Growing Usually Means That Compliance Gets Left Behind
You're moving quickly — hiring, building, scaling, maybe setting up a new facility or bringing a product through development. GMP, ISO and regulatory compliance don't slow down to let you catch up. These are the gaps that catch pharma, medical device and biotech companies out.
No Dedicated Compliance Resource Yet
You're relying on whoever has time — a founder, an ops lead, someone wearing five hats — while regulators expect a system that runs whether or not that person is in the room
A Facility Build That's Moving Faster Than Your Compliance Plan
Greenfield or brownfield, a new facility brings validation, qualification, CMC and documentation requirements that need to be built in from day one — not retrofitted once the equipment's already onsiteA QMS You've Already Outgrown
What worked at 5 people doesn't hold up at 50. Generic templates and systems built once, early, rarely scale cleanly — and retrofitting a bespoke system under pressure costs more than building one right the first timeFinding Out You're Not Ready When the Audit Is Already Scheduled
Inspection readiness isn't something you can build in the two weeks before a visit. By the time the gaps show up — in your QMS, your validation, or your product or device files — there's no time left to close them properly.
“Grounded program, no over inflated plans, stage appropriate and lean on budget. The QSN team is responsive and we kept to our overall timelines. QSN provided clear leadership and vision of what was needed aligned with the client-needs. Critically for our company, deployment of the QMS has elevated our attention to Quality at the right time of company life cycle – stressing the importance of grounded attention to compliance and setting the quality culture. QSN provided grounded expertise with care and attention to detail. Keeps client informed along the way. Aligns with the start up biotech structure.”
Chief Medical & Development Officer — GxP Clinical Biotech
One Partner Across Your Whole Compliance Journey
Most growing companies patch together compliance as they go — a QMS process here, a validation consultant there, whatever gets you through the next audit or the next facility inspection. QSN goes beyond QMS — covering CMC, validation, product development, greenfield and brownfield facility support, training and audits, as well as covering all elements within a QMS/PQS, including software - with one framework and one team, from your first system through to full GMP or ISO accreditation.
| What You Want | Without a Partner | With QSN |
|---|---|---|
| Site Licensing & Accreditation A licensed or accredited site, ready to operate | Applications delayed by gaps found late in the process | A staged path to GMP licensing or ISO accreditation, with gaps closed before the inspector arrives |
| Clinical Trial Readiness Confidence moving from R&D into clinical trials | Sponsor obligations discovered mid-trial, when they are costly to fix | Sponsor oversight, vendor qualification and GMP/GCP compliance in place before your trial begins |
| Quality Management Systems A quality system your team will actually use | A generic template, written once and rarely followed | A plain-language, right-sized system built around your product, processes and stage of growth |
| Regulatory Compliance Technical support that goes beyond documentation | Separate providers for validation, CMC, stability and environmental monitoring | One team covering validation, CMC support, stability programmes and environmental monitoring |
| Biz Transformation Electronic systems that support compliance, not undermine it | Software chosen on a sales pitch, then patched for data integrity after go-live | Compliance-first system selection and implementation, independent of any software vendor |
| Compliance 4 Life Ongoing compliance without a full in-house quality team | Systems that drift out of date between projects until something breaks | Retained support that keeps your system current as regulations and your business change |
| Audit 4 Life Confidence entering any audit or inspection | Preparation that starts only once an inspection is scheduled | An ongoing audit programme that makes inspection readiness a constant state, not a last-minute exercise |
| Training A team that understands compliance, not just follows it | One-off, generic training that is forgotten within weeks | Practical, role-based training through QSN Academy, delivered by consultants who work in the field |
See how working with QSN changes what’s possible for your business.
One Partner. Eight Areas of Transformation.
Whether you need support end to end, or just one piece of the puzzle, QSN works across eight areas — each built around your product, your process, and your stage of growth.
Site Licensing & Accreditation
The ProblemGMP licensing or ISO accreditation can feel like a black box — unclear requirements, unclear timelines, and no room to get it wrong.
What We DeliverPreparation and support through the full licensing or accreditation pathway — TGA, PIC/S, ISO 13485, ISO 17025, ISO 9001 — including gap assessment, documentation, and direct application support for new or existing facilities.
OutcomeA licence or accreditation achieved without unnecessary delay, rework, or guesswork.
Clinical Trial Readiness & Sponsor Compliance
The ProblemMoving into clinical trials brings sponsor obligations, GCP requirements and regulatory expectations that are easy to underestimate until you’re already behind.
What We DeliverSponsor compliance support, GCP readiness assessment, and preparation of the systems and documentation trial sponsorship requires.
OutcomeTrial-ready sponsor obligations met with confidence, not caught out mid-trial.
QMS
The ProblemGeneric templates rarely fit — and a QMS built once, early, is usually the first thing outgrown as a company scales.
What We DeliverBespoke QMS and PQS design, development and updates — including plain-language rewrites of existing procedures — built around how your organisation actually operates. Includes validation, CMC and product development support for greenfield or brownfield facilities.
OutcomeA quality system your team will genuinely use, and one that scales with you rather than needing to be rebuilt.
Regulatory Compliance
The ProblemInspection readiness isn’t something you can build in the two weeks before a visit — but that’s when most companies start. Records, CAPAs, deviations and non-conformances pile up faster than they’re resolved.
What We DeliverAudit-readiness support, internal audits, CAPA and deviation management, plus risk assessments, validation protocols and supporting studies for specific projects.
OutcomeWalking into any audit with confidence, not a scramble.
Biz Transformation
The ProblemPaper-based or fragmented systems slow you down and create compliance risk as you scale.
What We DeliverElectronic system selection and implementation — eQMS, eDMS, eLMS, LIMS — managed to keep compliance intact throughout.
OutcomeSystems that support growth instead of constraining it.
Compliance 4 Life
The ProblemStretched thin trying to keep on top of QMS upkeep, validation reviews and internal audits — without the budget for another full-time hire.
What We DeliverA dedicated senior compliance partner, year-round — ongoing support without the cost of an internal hire.
OutcomeConsistent compliance oversight, without adding headcount.
Audit 4 Life
The ProblemNot sure your internal audits would catch what a regulator will find.
What We DeliverA structured, ongoing audit program — internal, mock regulatory, and supplier audits.
OutcomeInspection-ready as a standing state, not a reactive scramble.
Training
The ProblemA compliant system is only as good as the team using it — and generic, off-the-shelf training rarely sticks.
What We DeliverRefresher and custom GxP/ISO training, upskilling, mentoring, and individual professional development including Plain Language procedure writing.
OutcomeA team that understands not just what to do, but why — reducing errors and reliance on any one person.
Our Framework
Every engagement follows the same QSN framework — whether you need support across all eight areas of transformation, or just one or two to meet your goals. It's the roadmap we use to scope, sequence and deliver every project, from your first system through to full GMP or ISO accreditation.
Check out our QSN framework below.
Six Pillars of Transformation
As part of Stage 3 of our framework — Begin the Transformation — QSN uses six pillars to guide delivery: Top Management, Team, QMS, Facility & Environment, Equipment, and Operational Processes.
Whether you're standing up a new greenfield or brownfield site, updating a QMS, running a validation project, or working through a single documentation gap, these six pillars give us the wider view — so nothing gets missed, and nothing gets over-engineered.
Led by Someone Who Has Done It Before
“Having worked with Kathy for many years, I can speak from first-hand experience of the exceptional quality of her work. Her honest, practical approach, and collaborative way of working is what makes her stand out from the rest. The improvements she identified and helped implement to the company’s internal audit program resulted in an ISO13485 TGA A1 audit rating. Kathy’s valuable service, knowledge and expertise is second to none. I highly recommend her and the QSN team to any company who wants a positive audit outcome.”
Senior Quality & Regulatory Manager — GMP/Medical Devices
QSN is led by Dr Kathy Walsh, whose consulting and industry experience spans quality and compliance, laboratory and product development, auditing, training, and licensing and accreditation across pharmaceutical, medical device and biotechnology sectors. Refer to our other Testimonials.
She is the author of Eliminating the Gobbledygook — Secrets to Writing Plain Language Procedures. QSN's approach — practical, phase-appropriate systems in place of unnecessary complexity — is drawn directly from this experience: developing quality systems that are genuinely used, not simply filed.
HOW TO TRANSFORM YOUR PROCEDURES INTO
USER-FRIENDLY DOCUMENTS USING PLAIN LANGUAGE
Learn how to eliminate:
Mix-ups, mistakes, high error rates or impacts from unclear, incomplete or incorrect documents
Inefficiency and decreased productivity
Negative impacts during development or manufacturing
Inspection deficiencies that impact time, cost and company reputation.
Not Sure Where To Begin?
Check out our Testimonials and a list of our favourite past projects.
You can check out our FAQs or review our detailed Case Studies.
The Services pages also include FAQs specific to the type of transformational work we support.
Book a complimentary enquiry call, and QSN will help identify precisely what your options are to accomplish your goals.
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