Medical Device & Pharmaceutical Regulatory Consultants

Compliance Management Solutions

Compliance Management Solutions is a team of TGA and regulatory consultants for medical device, IVD and pharmaceutical companies. We help manufacturers and sponsors reach the Australian market and stay compliant once they are there, and our international network extends that support across New Zealand, Asia, the USA, Europe and the UK. Our head office is in Melbourne, and we work with clients Australia-wide.

Our TGA and regulatory affairs work covers the whole path to market: regulatory strategy, device classification, technical documentation, ARTG inclusion and the post-market obligations that follow. Our team brings broad experience in regulatory affairs, project management and life sciences, and we are there to take the stress and worry out of bringing your medical device to market.

Where to start:

• TGA and regulatory affairs consulting
• Australian TGA sponsor for overseas manufacturers
• ARTG inclusion for medical devices and IVDs
• ISO 13485 consulting and MDSAP audit readiness
• FDA 510(k) submission support
• Pharmaceutical GMP and GDP training

See all our regulatory and compliance services, or contact us to discuss your product.