Success Stories Regulatory Affairs & Pharmacovigilance
Supporting US Companies with TGA Submissions and Market Access for Biologicals
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 detailed submission to the Therapeutic Goods Administration (TGA) for a gastroenterology indication, utilising a hybrid dossier approach that combined clinical data with a robust literature-based body of evidence. Our responsibilities included authoring the Clinical Summary and Overview documents, which comprised over 1,500 pages, strategically aligning the submission with TGA expectations for biologicals and medical device compliance, especially in scenarios where conventional clinical trials were not feasible.
For a second client operating in the cardiovascular health sector, we are currently supporting preparations for TGA GMP certification, a critical step in regulatory affairs that enables product registration and supply in Australia.
These engagements demonstrate our ability to guide international clients through complex regulatory pathways and successfully position their TGA submissions for biological products for regulatory approval in the Australian market.
Resolving Long-Standing Non-Compliance in a Recombinant Medicine
Client: Medium Sized European Pharmaceutical Company
Industry: Biopharmaceuticals / Recombinant Technology
Our expertise in recombinant DNA technology played a crucial role in assisting this client in resolving a long-standing non-compliance issue related to a couple of biologicals supplied to the Australian market. This challenge had persisted for over a decade, posing a significant risk in terms of regulatory affairs compliance. We were engaged to:
- Advise on TGA expectations for root cause analysis and suitable risk mitigation strategies.
- Support the development of corrective and preventive actions (CAPA) aligned with current regulatory standards, including medical device compliance.
- Assist in managing interactions with the TGA, which involved thorough correspondence, documentation for TGA submissions, and negotiation of regulatory outcomes.
Through our strategic guidance and effective engagement, our client successfully avoided both product recall and regulatory sanctions, thereby preserving the product’s market position in Australia and reinforcing the client’s reputation with local stakeholders.
Managing an Out of Compliance Event for a Prescription Medicine
Client: Medium Sized Global Pharmaceutical Company
Industry: Biotech Prescription Medicines / Urology
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, ensuring timely TGA submissions, and coordinated responses across global and local teams.
- Worked proactively with the client's Australian affiliate to maintain 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 affairs engagement, we helped minimise disruption to both the market and patient care.
Medical Affairs and Pharmacovigilance Success Stories
Enhancing Medical Information Processes for a Speciality Pharma Company in Australia
Client: Global Specialty Pharmaceutical Company
Therapeutic Area: Prescription medicine / Endocrinology
A global specialty pharmaceutical company sought support with managing medical information activities for a newly launched medicine 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 regulatory affairs 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 literature-based responses for commonly received medica enquiries
- Develop a triage and escalation process for complex or adverse event related queries
- Train internal stakeholders and third-party partners in pharmacovigilance compliant response handling.
Outcomes:
- Reduced average enquiry 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 materials for medical enquiries and advertising and local standards, supporting risk mitigation and market credibility
Key Success Factors:
- Deep knowledge of Australian regulatory requirements, including the nuances of the Therapeutic Goods 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.
Scalable Pharmacovigilance System for a Mid-Sized Pharmaceutical Company
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 system that integrated seamlessly with the client’s existing global safety framework. This included:
- Establishing an Australian Pharmacovigilance system aligned with both global processes and local regulatory expectations
- Appointing a local Pharmacovigilance contact (A-PVCP) 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 8 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 critical findings during TGA inspection within the first 12 months of operation
Key Success Factors:
- Our strong regulatory affairs understanding of both local and international pharmacovigilance frameworks
- Pragmatic designing systems that aligned with client structures while ensuring full Australian TGA compliance
- Efficient communication with the client’s global safety team to avoid delays and data fragmentation
Product Quality Complaints and CAPA Management for a Class IIa Medical Device
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 product 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 reportable adverse events to TGA within statutory timeframes to ensure regulatory compliance
- Communicating with the manufacturer to investigate quality complaints in alignment with their Quality Management Systems and TGA requirements
- Assisting in the assessment, conducting follow-ups, and creating final reports of events in line with TGA's Medical Device Incident Reporting Guide
- 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 regulatory affairs 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 team managing product quality complaints and global quality and design teams.
New Business Development Success Stories
Commercialising a Dermatologist’s Compounded Formula into a Compliant Product Range
Client: Australian Dermatologist
Industry: Skincare / Dermatology
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 affairs technical guidance to their formulation chemist
sto ensure the development of a stable and scalable formula.
- Authoring the full CTD Module 3 (Quality) dossier in alignment with TGA regulatory compliance 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.
Developing a Compliant and Distinctive OTC Product Range
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, particularly in relation to TGA submissions and market differentiation. Our services included:
- Marketing material review to advise on label content and design and 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 affairs input while fostering long-term product innovation and brand positioning in a highly competitive market.
Supporting Innovation in Organic Sunscreens for the Australian Market
Client: High-End US Cosmetics Brand
Industry: Cosmetics / Therapeutic Sunscreens / Complementary Medicines
We are proud to support a premium US-based cosmetics client renowned for its innovation in skincare. This company has been developing a range of sunscreens with organic herbal ingredients tailored to evolving consumer preferences and regulatory standards. From the early stages of product development, we provided ongoing regulatory affairs guidance to ensure:
- Full compliance with the Therapeutic Goods Administration (TGA) requirements for listed sunscreens and complementary medicines.
- Alignment of formulation, indication, claims on the labelling, and testing with both TGA regulatory expectations and market trends.
- Review of marketing materials to ensure compliance with the Therapeutic Goods Advertising Code.
Our proactive involvement across the development lifecycle has helped the client advance a new generation of sunscreens designed to meet the highest standards of efficacy, safety, and regulatory compliance in Australia’s highly regulated market.