Regulatory Strategy, Submissions

& Compliance

Regulatory Strategy

 

Our team has deep regulatory expertise that can identify, guide and fully support our clients through negotiations and formal appeals processes.

Lucid Health Consulting is an Australian Company, registered with the Australian Therapeutic Good Administration (TGA) and as such has a TGA Client ID. This enables LHC to act as a sponsor for companies wanting to submit a product registration to the TGA and to hold sponsorship for the product after registration by the TGA and listing on the Australian Register of Therapeutic Goods (ARTG).

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
  • Devices
  • IVDs

– Authorised representation and Product Sponsorship

– Quality Management Systems

– Post Market Surveillance and Compliance

– Promotional material review and Compliance

 

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

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