- Success in registering with Phase II data co dependent pathway experience
- Consideration in accessing the rapidly changing dynamics associated with FDA co approvals & ACSS
- Early negotiation with the TGA to secure strategy & approach
- Project management of quality applications
- Ongoing TGA management
The changing regulatory environment and trend towards globalization of our industry is allowing accelerated market approval, with the TGA piloting several new strategies. Work sharing initiatives with the US, European and some Asian countries is creating opportunity for fast assessment of dossiers that Australians have not experienced previously.
We have experience in recently accelerating over 10 Oncology and Haematology molecules to registration 30% faster than historical approval times. Finding the fastest pathway and minimising delays to ensure patients have access to your innovative medicine, is one of our passions.