Expedited compliance audit -
know every gap blocking your
product from market.

TGC's expedited compliance audit identifies every regulatory gap standing between your product and your target market. A structured risk scan across six compliance areas, with a prioritised action plan. Priced from $300.

From $300
Six compliance areas assessed
All major regulatory markets
Prioritised action plan included
When you need it

Eight situations that call for a compliance audit

If any of these describes your situation, an expedited audit is the right first step.

You are launching a product in a new market

You have a product ready to ship but have not confirmed what the destination market requires. We tell you exactly what you need before you commit to stock or distribution.

Your shipment has been held at customs

Customs authorities have flagged your product or placed it on hold. Our assessment identifies the specific non-compliance, what evidence is required, and the fastest path to release.

A marketplace has suspended or rejected your listing

Amazon, eBay, or a regional marketplace has removed your product or blocked your listing pending compliance documentation. We identify exactly what documentation is required.

Regulations have changed since your last assessment

EU, UK, US, or other market regulations have been updated and you are not certain whether your product still meets the current requirements. You get a current compliance position.

You are preparing for an investor or acquirer due diligence

An investor, acquirer, or auditor is reviewing your compliance position. We provide a structured, defensible assessment you can present with confidence.

You have received a regulatory query or enforcement notice

A regulatory authority has contacted you or issued a notice about a product. We map the specific gap and provides the regulatory references needed to respond.

You are reformulating or repackaging an existing product

A formulation change, new ingredient, or packaging update may trigger new compliance obligations. We confirm whether your changes affect your current market authorisation.

You want a compliance position before committing to market entry

You are evaluating whether a new market is viable for your product. You get the full compliance cost and effort picture before you invest in distribution, labelling, or registration.

What we assess

Six areas we assess. Every compliance gap identified.

A single compliance gap can block your product at customs, trigger a marketplace suspension, or expose you to regulatory enforcement. TGC maps every gap across the six areas that matter most for market entry.

Regulatory classification

Whether your product is classified correctly for your target market - and what that classification means for the requirements you must meet.

  • Product category determination
  • Applicable regulatory framework
  • Borderline product assessment
  • Classification-driven obligations

Labelling and packaging

Whether your label meets the mandatory requirements of your target market - mandatory elements, claims, language, warnings, and format.

  • Mandatory label elements
  • Claims compliance
  • Language requirements
  • Warning statement obligations

Safety testing and certification

Which safety tests, certifications, and conformity assessments are required for your product category in your target market - and which you already hold.

  • Required test standards
  • Certification requirements
  • Existing certifications assessed
  • Testing gap identification

Technical documentation

Whether your technical file, safety assessment, and supporting documentation meet the standards required for market access and regulatory inspection.

  • Technical file requirements
  • Safety assessment documentation
  • Declaration of conformity
  • Document retention obligations

Ingredient and formulation compliance

Whether your product formulation meets the ingredient restrictions, prohibited substance lists, and concentration limits of your target market.

  • Prohibited ingredient screening
  • Concentration limit review
  • Restricted substance assessment
  • Market-specific ingredient rules

Market notification and registration

Whether your product requires pre-market notification, registration, or authorisation before it can legally be placed on the market.

  • Pre-market notification requirements
  • Product registration obligations
  • Responsible person requirements
  • Market authorisation pathways
What you receive

One structured report.
Every gap ranked by priority.

Not a list of regulations to read. A clear assessment of where your product stands, what is blocking launch, and exactly what needs to happen next.

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Risk scan

Five-tier compliance status for every area

Every area assessed is given a standardised risk status.

Each of the six compliance areas is assessed and assigned a status on a five-tier scale. You know exactly where you stand in every area — and what level of urgency applies — before you make any decisions about next steps.

Major Non-Conformity — prohibited or immediately unlawful
Substantial Gap — launch blocker requiring regulatory action
Actionable Gap — corrective action required before or shortly after launch
Minor Gap — low-risk finding; addressable post-launch
Compliant — no action required
Regulatory

Specific regulatory references for every finding

Every gap linked to the exact regulation it relates to.

Every finding in the report is linked to the specific regulation, directive, or standard it relates to. Not general guidance - a precise reference you can take to your legal team, your manufacturer, or a regulatory authority.

Regulation or directive cited by name and article
Applicable to your specific product category
Market-specific - not generic global guidance
Action plan

Prioritised next steps with launch blockers first

Ranked actions so you know exactly what to do first.

The findings are translated into a prioritised action plan. Launch blockers - gaps that will prevent your product from reaching market - are ranked first. Each action specifies what needs to happen and who typically needs to own it.

Launch blockers clearly identified and ranked first
Pre-launch actions separated from post-launch obligations
Each action includes the corrective step required
Documentation

Documentation gap list

Every document you need vs every document you hold.

A structured comparison of the technical documentation required by your target market against what you currently hold. Tells you exactly which documents need to be created, updated, or translated before you can legally sell.

Required documents listed by category
Current documentation status assessed
Gaps identified with corrective action
Testing

Testing and certification gap list

Exact tests and certifications required vs what you hold.

The specific tests and certifications required for your product category in your target market, assessed against what you currently hold. Identifies exactly what testing needs to happen before launch and what certifications are missing.

Required test standards by product category
Existing certifications assessed for market validity
Missing certifications identified with test type
Example audit output - Food supplement product, Australia
Redacted real example — product and client details removed.
Major Non-Conformity Substantial Gap Actionable Gap Minor Gap Compliant
Product category Food supplement - oral capsule
Target market Australia
Applicable framework TGA / Therapeutic Goods Act 1989
Audit status Substantial Gap
Regulatory classification Launch blocker
Substantial Gap
Product contains active ingredients at concentrations exceeding AICIS industrial chemical thresholds. At assessed concentrations, the product meets the definition of a therapeutic good under the Therapeutic Goods Act 1989 and requires TGA registration prior to supply in Australia. AICIS listing is insufficient. Regulatory pathway must be amended before any supply or marketing activity.
Market registration Launch blocker
Substantial Gap
No ARTG listing exists for this product in Australia. Supply of a therapeutic good without a valid ARTG entry is a criminal offence under the Therapeutic Goods Act 1989. No supply, commercial importation, or advertising may occur until an AUST L number is issued. Estimated processing time is 3–6 months from a complete submission.
Labelling and packaging
Actionable Gap
Current label does not meet TGO 92 requirements for listed therapeutic goods. Required elements absent include: AUST L number (obtainable only post-registration), advisory statements for specified ingredients, dosage instructions in the mandatory format, and required warning statements. The existing label must be fully revised before supply.
Safety testing and certification
Actionable Gap
Existing safety data is adequate for AICIS purposes but does not meet TGA listed medicine standards. Microbiological testing to TGO 100 standards and heavy metals testing to Ph. Eur. standards are required for the ARTG application dossier. Existing data should be reviewed; additional testing commissioned where gaps are identified.
Ingredient and formulation compliance
Compliant
All ingredients assessed against TGA listed medicines permitted ingredients list (ARTG Ingredients Database). Each active ingredient is eligible for inclusion in a listed medicine at the formulated concentration. No prohibited or scheduled substances identified. Formulation is suitable for the listed medicine pathway subject to documentation requirements above.
1.2.1 Required steps to achieve compliance
1
Confirm TGA listed medicine pathway and appoint TGA sponsor Launch blocker - must be completed before any other registration steps. Regulatory reference: TGA Regulatory Guidance for Listed Medicines.
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This is a redacted real example — an actual TGC Expedited Audit with the client name, product name, and identifying data removed. The findings, regulatory analysis, and action plan are genuine. Request a quote to discuss your product →

The cost of not knowing

What a compliance gap costs when found at the wrong moment

This assessment exists to prevent outcomes that cost orders of magnitude more. These are the consequences TGC's audits are designed to prevent.

Expedited audit From $300 Know your position before you ship
Customs hold + storage $2,000 - $20,000+ Per consignment, plus delayed revenue
Product recall $50,000 - $500,000+ Logistics, remediation, and brand damage
Get your audit from $300 →

Customs hold and destruction costs

Products held at the border accrue daily storage fees. If the compliance issue cannot be resolved quickly, authorities can order destruction of the entire consignment at the importer's expense.

Marketplace suspension and delisting

Amazon, major retailers, and B2B procurement platforms suspend non-compliant products without warning. Reinstatement requires documented compliance evidence and can take weeks, halting revenue entirely.

Product recall and remediation

A regulatory authority-ordered recall requires removing products from sale, notifying buyers, and disposing of or re-labelling stock. The logistics and reputational cost of a recall typically runs into six figures.

Regulatory enforcement and fines

Enforcement actions from the FDA, MHRA, or EU competent authorities can result in Warning Letters, import alerts, and financial penalties. Warning Letters are public and affect brand reputation with retailers and investors.

Distribution agreement termination

Distributors and retailers have compliance clauses in their contracts. A compliance failure gives them grounds to terminate the agreement, end purchase orders, and delist your brand across their network.

Delayed or lost market entry

A compliance gap identified after launch is always more expensive than one identified before. Launch window, seasonal timing, and distribution commitments are all at risk when compliance is discovered late.

Client outcome

What clients say

"We were planning to launch in the EU within eight weeks. TGC's audit identified three launch blockers we hadn't accounted for - a missing Responsible Person, an incomplete Product Information File, and a CPNP notification we didn't know was required. The report gave us a clear action plan and we resolved all three before the launch date."

R.C. Head of Operations, Personal Care Brand
Common questions

FAQ - expedited compliance audit questions answered

An expedited compliance audit is a structured regulatory gap assessment for your product entering a target market. TGC reviews your product across six compliance areas — regulatory classification, labelling, safety testing, technical documentation, ingredient compliance, and market notification — and assigns each finding a status on a five-tier scale: Major Non-Conformity, Substantial Gap, Actionable Gap, Minor Gap, or Compliant. You receive a prioritised action plan ranked by urgency.
To scope your audit accurately, it helps to know your product category, your target market or markets, and any existing compliance documentation you hold (safety assessments, technical files, existing certifications). The more context you can provide, the more precise the scope and the quote. If you are unsure what to provide, contact us and we will guide you.
A label review specifically checks your product label artwork against labelling regulations for your target market. An expedited audit is broader - it assesses your entire product including formulation, ingredient compliance, registration requirements, safety testing, documentation, and market authorisation, not just the label. If you have a specific labelling question, a label review is often more efficient. If you need to understand your full compliance position before launch, the expedited audit covers everything.
Yes. If the audit identifies gaps that TGC's other services can address - label corrections, documentation preparation, or regulatory submissions - we will outline those options in the report and provide a quote for each. There is no obligation to proceed, but many clients use the audit as the starting point for a broader compliance programme.
TGC covers the major regulatory markets including the EU, UK, US, Australia and New Zealand, GCC, and key APAC markets. If you have a specific market requirement, contact us to confirm coverage before requesting a quote.