Regulatory & Compliance

Supporting product development, market access and ongoing compliance.

Overview

Life Sciences organisations operate within one of Australia's most heavily regulated industries. From product development and market entry through to commercialisation and post-market compliance, regulatory obligations play a critical role throughout the product lifecycle.

We advise pharmaceutical, biotechnology businesses, medical device manufacturers and healthcare organisations on the legal and regulatory issues that arise when bringing products to market and maintaining compliance in an evolving regulatory environment.

Explore how our team supports clients across Regulatory and Compliance in Life Sciences.


We advise clients on a broad range of TGA-related matters, including:

  • Product classification and regulatory strategy
  • Product registrations and listings
  • Medical device regulation
  • Advertising and promotional compliance
  • Product recalls and corrective actions
  • Regulatory investigations and enforcement action

Successfully bringing a product to market requires navigating Australia's pricing and reimbursement framework.

We assist clients with:

  • Market access considerations
  • PBS-related legal issues
  • Pricing and reimbursement matters
  • Government engagement and strategy

We help pharmaceutical companies navigate their obligations under the Medicines Australia Code, including:

  • Promotional and advertising reviews
  • Compliance reviews and investigations

When issues arise, we assist clients responding to regulatory investigations, compliance reviews, audits and enforcement action.

Our team works closely with clients to manage legal, commercial and reputational risk while achieving practical outcomes.

Clients we've supported

  • Bayer
  • AstraZeneca
  • Philips
  • Amgen
  • Edwards Lifesciences
  • Eli Lilly
  • Novartis
  • Eisai
  • Novo Nordisk

Get in touch

Our team to support you

Expertise in Life Sciences & Healthcare

Patents
Product Liability
Class Actions
Healthcare & Pharmaceuticals

How we can support you

Advisory

Get the full picture so you can make smarter decisions.

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Disputes

Early identification + strong representation = winning strategy.

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Projects

Your project can take years. And we're with you for the long haul.

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Regulatory

If you know what they need, you can help them make a good decision.

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Transactions

Are you ready to take that opportunity?

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