REGULATORY COMPLIANCE

The Risks of Letting Compliance Slip

If any of these sound familiar, your business is carrying compliance risk right now — not hypothetically, but actively:

  • "Our quality system records are out of control." CAPAs, deviations, non-conformances, complaints and management reviews piling up unresolved are one of the fastest routes to a major audit or inspection finding.

  • "We have an audit or inspection coming and we're not confident we're ready." Gaps found during pre-audit readiness activities are inconvenient. The same gaps found by a regulator during the real thing can delay licensing, certification, or product release.

  • "We're not sure our suppliers and vendors are properly qualified." Weak vendor assurance is one of the most common root causes traced back through nonconformances and product quality issues — and your accountability doesn't stop at the supplier's door.

  • "The regulations changed, and we don't know if we're still compliant." GMP, ISO and Australian Standards evolve. A gap analysis against current requirements is the only way to know for certain — waiting to find out during an audit is the expensive way to learn.

  • "Our validation and qualification protocols are behind." Missing, overdue or outdated validation documentation is consistently one of the most common findings across GMP and ISO frameworks alike.

  • "We need expert compliance support for a specific project, not a full-time hire or a long retainer." Sometimes the risk isn't a lack of expertise — it's not being able to resource a defined piece of work without over-committing budget or headcount.

Not sure where you stand? Find out if you would hold up under an inspection with our free scorecards for medical device or pharmaceutical compliance:

ISO 13485 Notified Body Inspection Readiness Scorecard

GMP Pharmaceutical Regulatory Inspection Readiness Scorecard

The Risks of Letting Compliance Slip

QSN provides GxP, ISO 13485 and ISO 17025 regulatory compliance and quality consulting for pharmaceutical, medical device, biotech, testing laboratory and medicinal cannabis businesses — as well as companies supporting those industries under ISO 9001, Good Wholesaling Practice (GWP) or Good Distribution Practice (GDP).

This service exists for exactly the situations above: when you need experienced, senior-level compliance support for a defined project or a set period of time — not an open-ended commitment.

Whether that's clearing a backlog of quality records, getting audit-ready before an inspection, qualifying a vendor, or simply keeping business as usual running compliantly while your internal team is stretched, we scope the engagement to the work that needs doing.

What We Help With

  • Strategy and compliance direction for business transformations and change projects

  • Pre-inspection and pre-audit readiness activities ahead of a licensing inspection or certification audit

  • Vendor and third-party audits, and vendor assurance — supplier and quality agreements, and supplier qualification

  • Gap analyses against changes in GMP regulations, ISO standards, or an Australian/International Standard

  • Process and procedural updates — process design, redesign and mapping, and QMS technical writing for established companies, including documenting new manufacturing lines, equipment, departments or facilities

  • Risk assessments — facilitating or drafting risk assessments and risk management systems to meet either ICH Q9 or ISO14971

  • Validation or qualification protocol development and supporting study protocol development

  • Clearing quality system records that are out of control — CAPAs, document reviews, non-conformances or deviations, complaints, management reviews and batch reviews

  • Product quality reviews and mock recalls and management reviews

  • Continuous improvement activities — Lean Manufacturing, Six Sigma, and strategies for improving quality culture

  • SME and stakeholder management to ensure procedures and processes are suitable for day-to-day activities

  • Stability programme development or review — design of new stability programs, or review of existing ones against your regulatory aspirations

  • Product development, design & development or CMC support — Chemistry, Manufacturing and Controls documentation, device design & development, specification development and management, and technical transfers

  • Equipment, method, cleaning and process validation — planning, protocol development and execution support across your validation program

  • Environmental monitoring programmes — design, review and ongoing management

  • Sponsor compliance covering GLP, GCP and GMP — for sponsors with obligations spanning non-clinical, clinical and manufacturing activities (see also our Clinical Trial Readiness & Sponsor Compliance page)

Who This Is For

We Support businesses operating under:

  • Pharmaceutical GMP - PIC/S, FDA CFRs, EU, etc. All medicine types

  • ISO 13485 for medical devices - all device types

  • ISO 17025 for testing and calibration laboratories

  • ISO 9001, for companies supporting these industries

  • Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP)

If you're not sure your business fits neatly into one of these categories, get in touch — it's very likely one of our consultants can still help.

Why Work With QSN

  • Scoped to the work, not a headcount commitment. You get senior-level compliance expertise for exactly the project or period you need it, without hiring or a long retainer.

  • Cross-industry regulatory depth. Our consultants bring hands-on QA, QC, validation, product development, auditing and manufacturing experience across pharmaceutical, medical device, biotech and medicinal cannabis clients.

  • We understand how compliance connects to the rest of your business. Regulatory compliance work rarely happens in isolation from your QMS, operations, site licensing or training needs — we work across all of it so nothing falls through the gaps.

  • Practical, not just technically correct. Our Plain Language approach means the protocols and reports, risk assessments and procedures we help you build are ones your team can actually follow — not just ones that satisfy an auditor on paper.

Frequently Asked Questions

What's the difference between this service and Compliance 4 Life or Audit 4 Life?

This service is project-based or time-bound — you engage us for a specific piece of work and the engagement ends when it's complete. Compliance 4 Life is a monthly retainer for ongoing, year-round compliance support, and Audit 4 Life is a structured, scheduled audit program run over time. Many clients start here and move to a retainer later if their needs become ongoing.

Our quality records (CAPAs, deviations, complaints) have gotten away from us — can you help?

Yes — clearing a backlog of quality system records is one of the most common projects we run. We can help you triage, investigate and close out overdue records, and put a more sustainable process in place going forward.

We have an inspection coming up in a few months — is that enough time?

Often, yes. Pre-inspection audit readiness projects are commonly run on a compressed timeline. The sooner we can complete a readiness assessment, the more time you have to close any gaps before the real inspection.

Can you audit our suppliers or vendors on our behalf?

Yes. We conduct vendor and third-party audits, and can support broader vendor assurance activities including supplier qualification and quality agreements.

Do you only work with businesses that already have GMP licensing or ISO accreditation?

No. Most of our regulatory compliance clients are already operating, but if you're still working toward initial licensing or accreditation, see our Site Licensing and Accreditation page instead.

Ready to Get Your Compliance Back Under Control?

Whether it's a looming inspection, a backlog of quality records, or a specific project you need expert hands for, we'll scope the support to exactly what you need — nothing more, nothing less.