Client Success Stories

Clients: Two US-Based Biologics Companies

Industry: Biologicals / Gastroenterology and Cardiovascular Health

We have been assisting multiple US-based clients with market entry strategies for high-value biological products in Australia.

For one client, we prepared a comprehensive submission to the Therapeutic Goods Administration (TGA) for a gastroenterology indication, utilising a hybrid dossier approach combining clinical data with an extensive literature-based body of evidence. 

Our responsibilities included:

• Authoring the Clinical Summary and Overview documents comprising over 1,500 pages.

• Strategically aligning the submission to meet TGA expectations for biologicals, particularly where conventional clinical trials were not feasible.

• For a second client in the cardiovascular health space, we are currently supporting preparations for TGA GMP clearance, a critical first step in enabling product registration and supply in Australia.

These engagements demonstrate our ability to guide international clients through complex regulatory pathways and successfully position their biological products for approval in the Australian market.

Client: Medium Sized European Pharmaceutical Company
Industry: Biopharmaceuticals / Recombinant Technology

Our expertise in recombinant DNA technology was instrumental in assisting this client to resolve a long-standing, inadvertent non-compliance issue affecting a medicine supplied to the Australian market.

The non-compliance had persisted for over a decade and posed a significant regulatory risk. 

We were engaged to:

• Advise on TGA expectations for root cause analysis and appropriate risk mitigation strategies.
   
• Support the development of corrective and preventive actions (CAPA) in line with current regulatory standards.
   
• Assist in managing interactions with the TGA, including correspondence, documentation, and negotiation of regulatory outcomes.
   

Through strategic guidance and effective engagement, our client was able to avoid both product recall and regulatory sanctions. This outcome preserved the product’s market position in Australia and reinforced the client’s reputation with local stakeholders.

Client: Medium Sized Global Pharmaceutical Company

Industry: Prescription Medicines / Regulatory Affairs

Our team was engaged to manage an urgent out of compliance event affecting the Australian supply of a prescription medicine with no therapeutic equivalent on the market.

Acting on behalf of our client, we:

• Led all communications with the TGA and coordinated responses across global and local teams.

• Worked proactively with the client's Australian affiliate to ensure continuity of supply wherever possible and mitigate regulatory risk.

• Supported the development of targeted communications to healthcare professionals, including guidance to specialists on rationing remaining stock and recommending possible interim treatment options for affected patients.

Through coordinated and strategic regulatory engagement, we helped minimise disruption to both the market and patient care.

Client: Australian Dermatologist

Industry: Skincare / Therapeutic Goods

We successfully supported the transformation of a compounded acne treatment, developed by an Australian dermatologist, into a fully TGA compliant product range, formulated, manufactured, and owned in Australia. This strategic commercialisation enabled our client to retire from clinical practice while retaining ownership of a thriving therapeutic brand.

Our scope of work included:

• Providing regulatory guidance to formulation chemists to ensure the development of a stable and scalable formula.

• Authoring the full Module 3 (Quality) dossier in alignment with TGA regulatory requirements, while coordinating with the client during ongoing stability studies.

• Advising on compliant labelling and website content in accordance with the Therapeutic Goods Administration (TGA) and Australian Competition and Consumer Commission (ACCC) requirements.

This project exemplifies our end to end support for healthcare professionals transitioning their clinical expertise into commercially viable and fully compliant therapeutic products.

Client: Multinational Generic Medicines Company

Industry: Over-the-Counter (OTC) / Consumer Healthcare

We have been engaged to support the development of an OTC product range for the Australian market, with a focus on regulatory compliance and market differentiation.

Our services included:

• Advising on label content and design to ensure alignment with the Therapeutic Goods Advertising Code, while preserving consumer appeal and clarity.

• Supporting the creation of a distinct positioning strategy for each product to enhance visibility and shelf presence in Australian pharmacies.

• Continuing collaboration with the client’s global and local teams to expand the product pipeline, including novel therapeutic indications for well-established small molecules.

This ongoing engagement reflects our ability to deliver strategic regulatory input while supporting long-term product innovation and brand positioning in a highly competitive market.

Client: Global Specialty Pharmaceutical Company

Therapeutic Area: Endocrinology

A global specialty pharmaceutical company sought support with managing medical information activities for a newly launched product in the Australian market. While the company had well-established systems and materials in Europe, they required local expertise to adapt and manage scientific communications in line with Australian regulatory expectations, particularly under the Therapeutic Goods Advertising Code and the approved product label.

Our Role:

We were engaged to establish a compliant, responsive medical information service tailored to Australian standards. 

We worked closely with the client's global and local medical teams to:

• Ensure all information provided to healthcare professionals and consumers was factually correct, evidence-based, and compliant with the Therapeutic Goods Advertising Code

• Improve and manage a database of standard responses for commonly received inquiries

• Develop a triage and escalation process for complex or adverse event-related queries

• Train internal stakeholders and third-party partners in compliant response handling

Outcomes:

• Reduced average inquiry response time by 40%, with improved accuracy and consistency

• Successful TGA audit outcome, with no critical findings related to medical information practices

• High client satisfaction and continued collaboration for post-launch product support

• Strengthened regulatory alignment between global content and local standards, supporting risk mitigation and market credibility

Key Success Factors:

• Deep knowledge of Australian regulatory requirements, including the nuances of the Advertising Code

• Close collaboration with the client’s regional and global teams to maintain scientific integrity while ensuring local compliance

• Flexibility to adapt systems and materials from international sources, reducing duplication and maintaining brand consistency

Client: Mid-Sized Pharmaceutical Company

Product Portfolio: Prescription Medicines and OTC Products

A mid-sized pharmaceutical company with a growing product portfolio in Australia needed to strengthen its local pharmacovigilance system to meet TGA expectations. While they had a global safety partner managing signal detection in other markets and aggregate reporting, they lacked robust local infrastructure to handle day to day safety data collection, reporting, and compliance in Australia.

Our Role

We were engaged to build and scalable, their local pharmacovigilance framework that integrated seamlessly with the client’s existing global safety systems. This included:

• Establishing an Australian PV system aligned with both global processes and local regulatory expectations

• Appointing a local PV contact to serve as the interface with the TGA

• Creating standard operating procedures (SOPs) tailored to Australian reporting timelines and requirements

• Boosting their literature monitoring strategy for Australian publications

• Supporting signal detection activities and maintaining a local safety database for post-marketing events

• Providing training to client teams and distribution partners

Outcomes:

• Achieved full pharmacovigilance readiness within eight weeks, including documentation, local contact assignment, and reporting processes

• Seamless integration with global safety systems, avoiding duplication and ensuring consistency of data across jurisdictions

• Built-in scalability, allowing the system to expand as the client’s product portfolio grew

• Zero findings during TGA inspection within the first 12 months of operation

Key Success Factors:

• Our strong regulatory understanding of both local and international PV frameworks

• Pragmatic designing systems that aligned with client structures while ensuring full Australian compliance

• Efficient communication with the client’s global safety team to avoid delays and data fragmentation

Client Type: European Medical Device Manufacturer

Product Class: Medical Device

A European manufacturer marketing a Class IIa medical device in Australia was receiving an increasing number of quality complaints related to product performance. Lacking an on-the-ground presence, the client needed local support to manage complaint intake, TGA reporting, sample coordination, and CAPA implementation.

Our Role:

We provided end-to-end post-market support, acting as the client’s Australian interface for:

• Logging all adverse events and quality complaints

• Communicating with the manufacturer to investigate complaints in alignment with ISO 13485 and TGA requirements

• Assessing and reporting events to the TGA within statutory timeframes

• Coordinating unit collection from Australian users

• Developing and implementing CAPAs to address recurring issues and improve design and safety

Outcomes:

• All reportable events submitted to TGA deadlines, maintaining full compliance

• Identified a recurring component issue through trend analysis, prompting global design improvements

• Complaint volume decreased significantly following implementation of targeted CAPAs

• Improved product performance and enhanced user satisfaction in the Australian market

• Strengthened collaboration between local post-market activities and global quality and design teams