Product Development and Commercialisation

New Business Development

Our regulatory and commercial expertise allows us to support business expansion strategies and facilitate market entry by:

Conducting regulatory risk assessments to identify potential hurdles and mitigation strategies

Developing regulatory roadmaps with key milestones, ensuring compliance and efficiency

Identifying competitive advantages through in-depth analysis of regulatory dossiers and public domain data

Fast-track approvals, and strategic drug repurposing

Assisting with mergers, acquisitions, and partnership evaluations to align with Australian regulatory requirements

Providing regulatory coaching and training, including AI-driven efficiency strategies for long-term business growth

Building Infrastructure for Growth

Establishing Australian subsidiaries and affiliates for international companies looking to expand into Australia

Acting as your extension in Australia, where we become the Sponsor of your product in Australia
Setting up corporate compliance frameworks, distribution networks, and pharmacovigilance structures
Ensuring regulatory compliance for startups and established pharmaceutical companies
Developing business models that meet TGA and other regulatory requirements
Supporting companies in navigating regulatory, legal, and operational challenges within the Australian healthcare system

Client Success Stories

Dermatologist – From Compounded Formula to Commercial Brand

We transformed a compounded acne treatment into a TGA-compliant OTC product range, fully owned and manufactured in Australia.

Scaling International Brands: Herbal Sunscreens for the Australian Market

From formulation to finished product, we guided a high end US cosmetics company through TGA requirements for developing sunscreens with herbal ingredients under both, sunscreen and complementary medicine pathways.

OTCs - Compliant OTC Range with Market Differentiation

We supported the development of a compliant OTC range, ensuring each product had clear, competitive positioning on pharmacy shelves.

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