Contact Info
Australia
Why would an Australian pharmaceutical sponsor or wholesaler hire an ERP consultant?
Australian sponsors, manufacturers and wholesalers need an ERP that carries ARTG entry details, scheduling and state licensing rules, PBS-related price changes, batch release and expiry control, and a fast, complete recall trace. I map those needs with your operations, quality and finance people, compare platforms independently and oversee delivery remotely. TGA interpretation and decisions on whether validation requirements apply stay with your QA and regulatory team.
Last reviewed by Vikas Saroj
I work remotely with pharmaceutical businesses around Australia: sponsors that import and supply registered medicines, manufacturers of prescription, over-the-counter and complementary medicines, contract manufacturers, and wholesalers that deliver to community pharmacies and hospitals across states and territories, often from a single national warehouse.
Australian medicines businesses juggle a particular set of rules. Each product has an entry on the national register with its own identifier. Scheduled medicines bring state and territory licensing and, for some, strict record keeping. PBS listings shape pricing, and the national recall procedure expects you to know exactly where every batch went.
I help you turn those obligations into practical ERP requirements, select software based on tested scenarios, and steer the build until it is stable. Interpretation of TGA requirements stays with your regulatory and quality team; my focus is a system that supports their decisions with accurate batch data, enforced rules and records they can rely on during an audit or a recall.
What I Do
I build the design around your products' regulatory identity, your batches' quality status and your customers' licenses, then test it before anything goes live.
Item master structures that hold each product's register entry, AUST R or AUST L identifier, schedule, pack sizes and storage conditions, each field owned by a named regulatory person and edits logged.
Requirements for customer license checks by state or territory, restricted storage, approvals on receipts and adjustments, and the registers your compliance staff need for the most tightly controlled schedules.
Price lists with effective dates, customer groups and PBS-related changes loaded in advance, so new prices apply on the right day and stock revaluation questions are raised before they surprise finance.
Batch genealogy from supplier lot to customer delivery, recall contact lists by customer type and a scripted recall exercise built into UAT and repeated after go-live.
Scripted demos on your own products: a batch release, a scheduled medicine order to an interstate customer, a price change day and a recall exercise, with every vendor judged against identical criteria.
Remote review of configuration, migration and test evidence against written requirements, coordinated with your quality team so their own review can draw on the project records.
What to Measure
An ERP for pharmaceutical should make these numbers available without a spreadsheet. I design the data model and reports around them from the start.
Platform Fit
How I Work
Products, schedules and channels
Product register and schedule list
State and territory customer mix
Batch release steps
Current recall process
Controls, pricing and platform
Item and batch data model
Schedule-based order controls
Price change procedure
Weighted platform scoring
Proven before switch-over
Recall exercise in UAT
Batch and price data loaded
License checks tested
Early operations support
In Australia, the sponsor is the business responsible for a medicine's entry on the national register and for supplying it. Some sponsors manufacture locally; many import finished product and use a third-party logistics provider. Contract manufacturers make product for other sponsors. Wholesalers buy from many sponsors and deliver to pharmacies and hospitals, often daily and across long distances.
The ERP design follows the role:
I start every engagement by confirming which of these roles you play, because many businesses play two. For the generic flow, see my pharmaceutical ERP overview; award-based labor costing and other plant topics live on my Australian manufacturing ERP page; this page stays with medicines.
Every medicine supplied in Australia has a register entry, and the type of entry matters. Registered medicines carry an AUST R number, while listed medicines, including many complementary medicines, carry an AUST L number. Each product also has a schedule that affects who can buy it and how it must be handled. Licensing for wholesale supply of scheduled medicines is managed at state and territory level, so a wholesaler supplying several states holds several sets of obligations.
In ERP terms, this becomes structured data and rules:
What the rules should be is decided by your compliance lead and regulatory team, using current TGA and state guidance. The ERP then has to enforce whatever they decide, and that the requirements are clear enough to test during UAT. I gather and document these rules through my requirements gathering process.
For medicines listed on the Pharmaceutical Benefits Scheme, the government-subsidized price shapes what sponsors and wholesalers charge, and listed prices can change. For a sponsor, each change can affect contract prices, wholesaler terms and the value of stock already on hand. For a wholesaler, it affects what pharmacies are invoiced from a given date and how quickly price files from many suppliers are loaded.
An ERP that relies on someone editing prices on the morning they change will eventually get it wrong. The requirements I write cover:
Non-PBS lines, such as over-the-counter and complementary medicines sold to pharmacy groups and retailers, bring promotional pricing and rebates instead. I keep the two pricing worlds clearly separated in the design. How GST applies to different medicines and how revenue is recognized are confirmed with your accountant. Pricing rules form part of the scenarios I run during ERP evaluation.
Australia has a national procedure for recalling therapeutic goods, and a recall can be required at different levels of the supply chain, from wholesalers to pharmacies to patients. The ERP's job is to answer three questions fast and completely: which customers received the batch, which source lots or components went into it, and how much remains in stock or in transit. I build a recall exercise into UAT using a randomly chosen batch, and recommend repeating it on a set schedule after go-live.
Distance is the other constant. Product may travel enormous distances by road between a distribution center and a remote pharmacy, through very hot conditions in the north and inland. I write requirements for storage ranges per item, shipping methods by route and season, logger data tied to batches in transit, and a block on any affected batch while the quality team reviews the temperature record.
Finally, I write down the jobs the ERP should leave to other systems. Deviation management, CAPA, complaint handling and controlled documents are better kept in a quality management system, and test results in a LIMS where one exists. The ERP holds the batch decision. That clear split gives your quality team a defined scope when they assess what validation the system needs.
Australian pharmaceutical businesses commonly start from MYOB or Xero plus a separate stock app, or from an older wholesale system. A move to a full ERP brings across batches with status and expiry, items with register and schedule data, customer license records by state, price lists and open purchase orders with overseas suppliers. Each data set is reconciled and signed off by its owner in quality, warehouse or finance before cutover.
Choosing a platform comes down to your role, your product mix, the number of states you supply and the systems the ERP must talk to: 3PL, QMS, temperature monitoring and pharmacy ordering channels. The platform notes below set out a first view, and the scored comparison happens with your own scenarios.
I work remotely with businesses in every state and territory, using video workshops, shared diagrams, a referenced requirement list and recorded test sessions. Workshop times are set so Perth, Adelaide and east coast teams can all join. A walkthrough of a warehouse or packing room on video is normally enough, and meeting in person can be arranged where it adds real value. For other engagements in the country, see my ERP consultant Australia page or the Australia hub.
Tell me about your business and current systems. I’ll suggest the most sensible first step.
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Not sure which ERP you need?
Share your business requirements with me and I will help you understand the right process, architecture and platform before implementation.
FAQ
Yes. Register identifiers, entry type, schedule and storage conditions can be held as item fields with a named owner and change control. The design work is deciding which fields are mandatory, who maintains them and which processes use them, such as customer license checks and recall reports.
By loading approved price lists with effective dates before the change, so new prices apply automatically on the right day. I also define reports showing the effect on stock on hand and open orders, and rules for correcting invoices raised at the wrong price. Accounting treatment is confirmed with your accountant.
No. Regulatory interpretation belongs to the people in your business who own regulatory affairs and quality, along with their advisors. I translate the rules they set into system requirements, such as order blocks, restricted locations and approval steps, and test that the ERP applies them consistently.
Often less than a manufacturer, but the data exchange with the 3PL becomes critical: receipts with batch and expiry, release status, orders and dispatch confirmations. I size the scope around those flows, which keeps production modules you would never touch out of the budget.
Every business is different. Share where you are today and what you want to fix, and I’ll tell you honestly whether and how I can help.
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Insights
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