Regulatory Affairs, Quality and Advocacy
Our highly experienced Regulatory, Quality, and Compliance team possesses in-depth knowledge of the complex regulatory environment in Australia and the Asia-Pacific region. With deep regulatory expertise, our team is adept at identifying, guiding, and fully supporting our clients through negotiations and formal appeals processes.
We position your products for the best possible outcomes by expertly navigating the challenges during the approval and life-cycle management process. Including:
- Developing effective submission strategies
- Ensuring compliance with regulatory requirements
- Managing submissions
- Enhancing your regulatory, quality, and compliance activities
- Lifecycle management strategies
Our Regulatory Affairs, Quality and Advocacy Services
We specialise in providing advice and implementation of:
Regulatory Strategy
- Regulatory intelligence and product positioning
- Regulatory feasibility and gap analysis
- Pre-submission meetings
- Regulatory submission planning, timelines and fees
- Global market strategy
Regulatory Submissions
- Medicines
- Biologicals
- Devices
- IVDs
Quality Management Systems
Post Market Surveillance and Compliance
Promotional Material Review and Compliance
Rely on our expertise to ensure your products achieve a successful launch and long-term success in the Australian market.
Get in touch with us today to discover how we can help your pharmaceuticals, biotech products, medical devices, and technologies successfully enter the Australian market.
An IQVIA Business
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IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries and is dedicated to delivering actionable insights and accelerating innovations. Learn more at www.iqvia.com
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