Regulatory Affairs, Quality and Advocacy

 

Regulatory Strategy

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.

Lucid Health Consulting are providers of expert advice in health economics, pricing & reimbursement, market access and regulatory affairs in Australia. Enabling companies to optimise the entry of their pharmaceutical, biotech and medical devices into the Australian market.

ADDRESS

32 Mitchell St, McMahon's Pt NSW 2060

GET IN TOUCH

15 + 7 =