,
2 min read
In the fast-paced world of pharmaceuticals, biotechnology, and medical devices, regulatory compliance does not end with product approval. Maintaining a product’s presence in the market requires continuous engagement with regulatory authorities and proactive life cycle management (LCM). For companies operating in Australia, where the Therapeutic Goods Administration (TGA) enforces strict and evolving requirements, having a robust system for query handling and LCM support is essential.
What is Regulatory Query Handling?
Regulatory query handling refers to the process of managing, responding to, and resolving questions or requests for clarification from regulatory agencies such as the TGA. These queries may arise during:
- Pre-market approval reviews
- Post-market surveillance
- Variation submissions
- Pharmacovigilance reporting
Prompt, accurate, and compliant responses are critical. Delayed or incomplete answers can stall approvals, cause compliance gaps, or even lead to product withdrawals.
What is Life Cycle Management (LCM) in Regulatory Affairs?
Life cycle management involves overseeing a product’s entire journey — from development and launch to post-approval maintenance and eventual discontinuation. In Australia, LCM activities typically include:
- Post-approval variations (minor and major changes)
- Labeling updates in line with safety or regulatory requirements
- Renewals and re-registrations
- Periodic safety updates
- Manufacturing site changes
- Regulatory impact assessments for global changes
Effective LCM ensures products remain compliant, safe, and market-ready, even as scientific, regulatory, or business conditions evolve.
Challenges Companies Face in Australia
- Complex TGA guidelines that require local expertise.
- Navigating different timelines and submission formats for various product categories.
- Coordinating global regulatory changes for products marketed in multiple countries.
- Managing multiple queries while maintaining day-to-day compliance activities.
Without dedicated local resources, global companies often find these processes time-consuming and prone to delays.
How Freyr Australia Adds Value
At Freyr Solutions, our Australia-based regulatory experts offer comprehensive query handling and LCM support tailored to the TGA environment. Our team ensures:
- Swift Query Resolution – Coordinating with internal stakeholders to draft scientifically accurate, regulator-friendly responses that meet deadlines.
- Proactive LCM Management – Monitoring regulatory changes and ensuring timely updates to labeling, dossiers, and product details.
- Global-Local Alignment – Adapting global regulatory strategies to meet Australian requirements without duplication of effort.
- TGA Liaison – Acting as your trusted communication bridge with the TGA for smooth information flow and faster approvals.
- Document & Submission Management – Leveraging technology-driven solutions for efficient dossier preparation and tracking.
Why This Matters for Your Business
Efficient regulatory query handling and life cycle management are not just compliance necessities — they are competitive advantages. By resolving queries quickly and maintaining up-to-date product registrations, companies can avoid costly interruptions, protect market share, and uphold their reputation with both regulators and healthcare professionals.
With Freyr Australia, you benefit from local TGA expertise, global regulatory experience, and proven operational efficiency — ensuring your products stay compliant, competitive, and ready for patients in Australia.
Freyr Solutions — your partner for seamless query handling and life cycle management in Australia.
