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Pharmaceutical & Medical Devices

Why TGA Compliance Is Essential.

One Claim Can Cost Millions.

Or Build Market Authority.

A single unsubstantiated claim can trigger TGA investigation, financial penalties, or forced product withdrawal.
In 2024, 67% of TGA enforcement actions targeted digital campaigns and healthcare professional materials.

Quick Content Compliance Checklist

Every claim supported by robust clinical evidence
No off-label promotion or patient guarantees
Comparative statements are substantiated and approved
Content dual-reviewed by legal and regulatory experts
No testimonials or before/after images

What We Deliver

Evidence-Based Product Pages

Translate clinical data into compelling, compliant copy.

Device Launch Kits

Position new medical technologies for approval and adoption.

Professional Education Content

Engage clinicians and KOLs with peer-reviewed, guideline-safe material.

Competitive Positioning

Stand out with substantiated product comparisons - don’t risk unapproved claims.

Regulatory Expertise You Can Trust

All content is reviewed by legal professionals and regulatory affairs specialists.
We understand the difference between Class I and Class III requirements, device software, ARTG listing, and sponsor obligations.
Our specialists have managed regulatory enforcement responses and know the latest precedents.

How We Work

Audit

Identify compliance gaps and messaging risks.g.

Evidence Strategy

Align content with your strongest clinical assets.

Content Creation

We draft or rewrite product pages, device launch kits, professional education materials, and patient resources, all aligned with TGA, ARTG, and relevant Australian law

Regulatory Intelligence Loop

Stay ahead of changes. Adapt quickly. Stay safe.

FAQs

Frequently Asked Questions

Can I use published studies to support my product claims?

Yes, if they are peer-reviewed, current, and directly relevant. Every reference is checked for TGA alignment.

Can I highlight advantages over competitors?

Yes, if substantiated by approved data and never implying off-label uses.

How do I keep up with changing guidelines?

We monitor TGA updates and offer rapid content revisions – usually within 48-72 hours.

What about healthcare professional materials?

We build compliant, evidence-based content for professional audiences, always within TGA’s communication boundaries.

Get in Touch

Our content solutions blend industry expertise with persuasive storytelling to attract, engage, and convert your ideal clients.

Because a brand without a voice is a brand that’s easily forgotten. 

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