Helping your business achieve the optimum commercial outcome for your products
Navigating the path to regulatory approval and compliance
Our highly-experienced Regulatory team have in-depth knowledge of the complexity of the regulatory environment in Australia and New Zealand. We help to position your products for the best possible outcomes by navigating the various challenges during the approval and life-cycle management process.
We will assist you in the development of effective submission strategies, ensure you are meeting your regulatory requirements, manage your submissions, and enhance your regulatory activities.
Our consultants have expertise across prescription, over-the-counter (OTC) and complementary medicines, medical devices including in vitro diagnostics and software as a medical device, sunscreens, and cosmetics. We also have electronic publishing experts, who are adept at using a range of software solutions to enhance your regulatory, quality and compliance obligations.
We can help you
We have a trusted history of success, managing over 160 projects each year, including the submission of 60 major applications to regulatory authorities. As such, we understand your unique needs and are perfectly positioned to optimise your business.
• GMP Clearance Requirements and Submission Strategies Advice
• GMP Clearance Applications – MRA & CV Applications, TGA Certification (Inspection) Requests
• Post Submission Priority Requests
• GMP Clearance Monitoring and Maintenance
• Certificates of Pharmaceutical Product (CPP) applications
• Free Sale Certificates (FSC) applications
• Export Certificate applications
• Advice on legalisation requirements
• Document certification and legalisation
Clients Across the globe
Major applications on average each year
GMP Clearance applications submitted in 2024
Regulatory projects in the past 12 months
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Maria Dionyssopoulos
Head of Regulatory, Quality and Compliance
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of...
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