Regulatory Affairs Service

Transitioning from pharma candidate to marketed product GreenLight Clinical

At GreenLight Clinical our dedicated Regulatory Affairs Team provides expert advice and services to the pharmaceutical and healthcare industries, both within Australia and around the world. Comprising professionals who have previously held similar roles in large, multinational companies, we can assist you with securing registration of the following:

  • Prescription medicines – including solid, injectable and topical dosage forms, and other specialised delivery types (e.g., ophthalmic, respiratory products)
  • OTC medicines
  • Complementary medicines
  • Nutraceuticals and health supplements

Advice and Services

The requirements for commercial registration – from technical documentation through reimbursement and on to post-marketing information – necessitates a wealth of expertise. GreenLight Clinical can undertake the necessary diligence to advise and/or help with:

  • Preparation of all pre- and post-approval submissions
  • Literature-based submissions
  • Identification of data requirements for key markets
  • Technical documentation and scientific justifications (process and validation reports, pharmaceutical development reports, stability monitoring/trending etc.)
  • Health Authority pre-submission meetings
  • Project management
  • Reimbursement
  • Agency representation and non-commercial sponsorship
  • Product Sponsorship transfers
  • Artwork, PI and CMI management Specialised Submissions

Specialised Submissions

Alternative approval pathways offer a significant opportunity. Our team can help evaluate and develop such specialised submissions, including:

  • Special access scheme applications
  • Orphan drug designations
  • Fixed-dose combination applications