Regulatory Affairs Consulting Services

Comprehensive Regulatory Affairs Support including Gap Analysis, Product Registration - TGA regulatory approval and post-market regulatory compliance

We assist clients in achieving seamless regulatory approvals by implementing a strategy specifically designed for Australia’s regulatory compliance framework, particularly for TGA compliance. Some of our sought-after pharmaceutical consulting services include:

Regulatory gap analysis and dossier bridging for streamlined TGA regulatory compliance
New product registration for pharmaceuticals, biologicals, medical device, and cosmetics
Literature-based submissions
Post-approval variation submissions
Product lifecycle management and comprehensive post-market regulatory compliance oversight
Authoring CTD dossier modules, including Risk Management Plans (RMPs), and Australian-specific Module 1 documents
Developing strategies for product registration pathways to fast-track regulatory approvals, maximising commercial opportunities
Optimising internal regulatory processes for start-ups and multinational affiliates, improving efficiency and regulatory adherence.

Broad Expertise

Regulatory Affairs Team

With the addition of RegulatoryEdge Consulting to our team in 2024, we've enhanced our in-house regulatory capabilities and broadened our pharmaceutical consulting offerings. Our senior consultants bring decades of hands-on experience across small molecules, biotech products, biologicals, medical device(s) and cosmetics ensuring smooth, successful product registrations. Our clients trust us with high-stakes filings and complex product types, relying on our expertise to ensure TGA regulatory compliance and to ease the pressure on lean in-house teams.

Our Real World Regulatory Affairs Results

Literature-Based Submission for Biological

For a US-based biologicals company, our regulatory affairs team authored over 1,500 pages of a hybrid literature based submission, supported by more than 80 medical publications. We achieved TGA compliance and received regulatory approval for the desired gastroenterology indication.

Addressing Long Standing Non Compliance in a Biotech medicine

We supported a European pharmaceutical client in resolving a decade-long manufacturing oversight related to their recombinant DNA medicine. Through our pharmaceutical consulting expertise, we guided root cause analysis and corrective actions to help them achieve regulatory approvals and ensure TGA compliance. This collaborative effort allowed them to regain regulatory compliance, avoid recalls and penalties, and preserve the product’s market access in Australia.

Managing Market Continuity During a Compliance Crisis

A global pharma client relied on our pharmaceutical consulting and regulatory affairs expertise during an urgent out of compliance event involving a critical Rx product with no therapeutic equivalent. We coordinated all TGA compliance and regulatory approvals communications, including those to medical specialists, to ensure market continuity and avoid disruption to patient care.