Practice / Services
Specialist counsel across the full regulatory lifecycle.
Expert advice on your individual regulatory needs against the specific and requirements and risk profile of your portfolio. Whether you are at the beginning of your medtech journey or looking to expand or safeguard your existing portfolio, we can work with you as your principal regulatory consultant or as an extension of your regulatory team — accountable, technically rigorous, and direct.
Practice Areas
Scope of services
Commercial in confidence communications, with your business and between regulators and manufacturers.
TGA Submissions
TGA Submissions and ARTG Reviews
End-to-end management of ARTG listings, registrations, and variations for therapeutic goods entering the Australian market.
Deliverables
- ARTG entry strategy and pre-submission planning
- Maintain manufacturer relationships and confirm conformity assessment responsibilities before and after registrations.
- Document review and manufacturer evaluation
- Application drafting and electronic lodgement
- Response to TGA clarification requests
- Variation submissions for approved products
- Comprehensive audits of current registration to streamline regulatory compliance, improve and reduce regulatory costs and manage ‘scope creep’ in classification.
- Consent to supply outside the Essential Principles and supply of unapproved therapeutic goods into the Australian market.
- Facilitating Unique Device Identification (UDI) requirements and importing into the Australian AusUDID.
- MDD to MDR Conformity Assessment assistance
Dossier Preparation
Dossier Preparation
Compilation of technical and regulatory documentation aligned to current TGA and international jurisdictions expectations.
Deliverables
- Medical device Technical Files
- Risk assessments and Essential Principles checklists
- Determining applicable ISO Standards
- Risk analysis and FMEA method
- Clinical Evidence Review writing
- Quality, non-clinical, and clinical overview drafting
- Gap analysis and remediation
Sponsor Representation
Sponsor Representation
Acting as your Australian sponsor under the Therapeutic Goods Act for overseas manufacturers and distributors.
Deliverables
- Sponsor of record for ARTG entries
- Maintaining documentation for Sponsor obligations for ongoing monitoring and reporting.
- Commercial in confidence communications, with your business and between regulators and manufacturers.
- Direct interface with TGA delegates
- Regulatory correspondence and reporting obligations
- Distributor authorisation management
Post-Market Compliance
Post-Market Compliance
Ongoing surveillance, and incident management for products on the ANZ market.
Deliverables
- Maintaining documentation for Sponsor obligations for ongoing monitoring and reporting.
- Distribution records
- Medical device annual reporting
- Maintaining documentation and regulatory compliance for post market audits
- Recall coordination and field corrective actions
- Adverse event responses and notifications to regulatory bodies and customers (consumer, health professionals and healthcare facilities)
- Assisting with device and medicine supply shortages
Labelling & Advertising
Labelling & Advertising
Compliance review for product labelling, packaging, permitted indications, and consumer-facing advertising material to the unique Australian requirements.
Deliverables
- Therapeutic Goods Advertising Code review
- Permitted indications matching
- Instructions for Use, product inserts and regulated patient information requirements
- Pre-publication review of marketing material, social media and health professional advertising
- TGO 91 and TGO 92 compliance assessment
Quality Systems
Quality System Implementation and Reviews
Quality management guidance and inspection readiness for sponsors, manufacturers, and contract sites performed by a qualified ISO 13485:2016 auditor.
Deliverables
- SOP development and review
- QMS Gap analysis
- Mock inspections and CAPA support
- Manufacturing site clearance applications
- Mergers and acquisition assistance