Pharma and health companies live in a paradox. On one side, there’s relentless pressure to expand with new markets, new products, new subsidiaries. On the other, regulators are breathing down your neck, demanding every pill, vial or device be traceable to the last digit. Growth and compliance don’t always sit easily at the same table. But in this sector, they have to.
It’s not enough to have solid R&D or great distribution partners. If your systems can’t prove, in real time, where that batch of injectable or supplement came from, or if your finance team is drowning in manual reconciliations before an audit, the brakes get slammed on expansion.
The regulatory landscape is an always moving target
If you’re operating in Australia or New Zealand, you will be aware of The Therapeutics Good Administration (TGA) who are tasked with keeping a tight rein on medicines and devices locally, and Medsafe plays a similar role across the ditch in New Zealand. Both lean heavily on global GMP principles, so if your processes can’t stand up to those checks, you’re in trouble.
The TGA has been busy tightening expectations around data integrity and electronic record-keeping. Meanwhile Medsafe is quick to align with EMA or FDA guidance when new risks emerge. What passed muster two years ago can suddenly look flimsy when a new standard drops.
That’s why it feels risky to leave compliance living in spreadsheets or siloed systems. When a regulator asks for proof – whether it’s batch traceability, recall readiness or a clean audit trail – you need to be able to pull that up on the spot. If your team is scrambling through disconnected files, the stress shows and regulators pick up on that straight away.
Pain points that slow health and pharma down
The problems most health and pharma businesses run into aren’t exotic. They’re painfully familiar – and they tend to show up at the worst possible time.
Batch traceability that doesn’t hold up under pressure | It’s one thing to say you can trace a product from supplier to shelf. It’s another to do it instantly, across multiple plants, subsidiaries and geographies, when a regulator calls.
Recalls that turn into reputation damage | Every business in this space knows recalls happen. What matters is how fast you identify the scope and prove corrective action. Without accurate, centralised data, recalls can quickly spiral into brand-eroding chaos.
Regulatory audits that drain resources | Auditors don’t care how many late nights your finance team put in to prepare. They just want consistent, provable data. If that means hunting through disconnected systems, expect higher costs, longer audits and more findings.
Multi-entity reporting that never adds up cleanly | As companies expand into new regions or spin up new entities, reporting becomes overly time-consuming. Consolidations drag on, intercompany eliminations go missing and leadership ends up making decisions off stale numbers.
GMP compliance gaps hiding in plain sight | Good Manufacturing Practice sounds straightforward until you try to evidence it across every process. Paper trails and patchwork systems leave dangerous blind spots;
Why compliance and growth clash so often
The tension comes down to this – compliance demands rigour, growth demands flexibility. One wants control, the other wants speed. Without the right systems, businesses end up compromising both:
- Speeding up new product launches but cutting corners on documentation
- Expanding into a new market while still juggling regional tax compliance in Excel
- Adding subsidiaries without upgrading the core finance or inventory platform
It’s not that leaders don’t care about compliance – it’s that they’re forced to prioritise the urgent over the essential. Until the day regulators, investors or customers call them on it.
The smarter way forward
This is where modern cloud ERP, built with health and pharma in mind, starts to change the game. We’re talking about a system that can:
- Capture every batch, lot and serial number automatically
- Track expiry dates, quality checks and deviations without manual workarounds
- Consolidate reporting across entities and currencies
- Generate audit-ready reports at the click of a button
- Provide role-based access and full audit trails regulators love to see
The beauty here isn’t in replacing people. It’s in giving them space to do higher-value work, because they’re no longer stuck firefighting data problems.
Case in point – scaling with confidence
To understand what happens when you stop patching processes and put a proper system in place, you can look to two Annexa customers, Life Cykel and Life-Space Group.
Life Cykel
Starting as a biotech focused on sustainable mushroom products, Life Cykel hit the classic scale problem – multiple markets, expanding product lines and strict traceability requirements. With NetSuite, they moved from disconnected systems to a single platform that tracks every batch, automates reporting and supports rapid international growth. Compliance became something they could demonstrate on demand allowing them to successfully enter big box retailers in the US
Read the Life Cykel case study →
Life-Space Group
Known for their probiotic and wellness brands, Life-Space faced the challenge of scaling a complex global supply chain while meeting tight TGA and Medsafe rules. Their NetSuite implementation gave them a unified view across production, distribution and finance – with built-in audit trails and recall readiness.
Read the Life-Space Group case study →
Do not underestimate the cost of inaction
It’s tempting to think that you can just deal with compliance once you’ve grown bigger. But that’s like saying you’ll build the plane while flying it. The longer compliance is left to patchwork systems, the more risk compounds:
- Lost sales from delayed recalls
- Heavier audit costs
- Fines and penalties
- Talent burnout as teams carry the weight of broken processes
Investors notice, too. In regulated industries, shaky compliance undermines valuations faster than a supply chain hiccup.
How to start untangling compliance and scalability
A few practical steps can move health and pharma businesses out of firefighting mode:
- Audit your current systems – map where compliance data lives today and how
- accessible it really is
- Prioritise high-risk processes – batch traceability, recalls and audit readiness usually sit at the top
- Bring finance into the conversation early – compliance ius both a manufacturing and reporting issue
- Think global from day one – even if you’re domestic now, expansion is faster when multi-entity reporting is already built in
- Invest in integration – a single system of record beats a tangle of point solutions every time
Scaling and compliance are not opposites
It’s easy to frame compliance as the enemy of growth, but in pharma and health, the two are inseparable. The companies that thrive don’t treat audits as a distraction from expansion. They treat strong compliance as the foundation that makes growth sustainable.
Because at the end of the day, regulators and investors are looking for the same thing – evidence you can scale without losing control.
The health and pharma sector doesn’t get the luxury of choosing between compliance and scalability. You need both, all the time, everywhere you operate. The real question isn’t whether you can keep regulators happy. It’s whether you can design systems and processes that let you grow without fearing the next audit, recall or regulatory change.
When you crack that, growth stops being a gamble. It becomes the natural outcome of a business built to scale in a regulated world.
Curious about what ERP could do for you?
Talk to the team at Annexa – we’ll walk you through the options and help you find the right fit.