Expert Regulatory Affairs Services for Regulatory Compliance

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 Product registration compliance framework. Some of our sought-after services include:

Regulatory gap analysis and dossier bridging for streamlined TGA regulatory compliance

New product registration for pharmaceuticals, biologicals, medical devices and cosmetics

Literature based 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 Strategy 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 Team

With the addition of RegulatoryEdge's 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 devices and cosmetic 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.

Real World 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 over 80 medical literature publications. We achieved TGA compliance and received regulatory approval for 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. By guiding root cause analysis and corrective actions, we brought them back into regulatory compliance, helped avoid recall and regulatory penalties, preserving the product’s market access in Australia.

Managing Market Continuity During a Compliance Crisis

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