In depth Regulatory Affairs support

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Our dedicated Regulatory Affairs team provides advice and services to the pharmaceutical, medical device and healthcare industries within Australia and around the world. Comprising professionals who have similar roles in large, multinational companies, we can assist you to secure registration of the following

  • Prescription medicines – including solid, injectable and topical dosage forms, and other specialised delivery types (e.g. ophthalmic, respiratory products)
  • Biosimilars
  • Biologics
  • Generics
  • Medical devices
  • 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 experts. 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, including PBS, Prosthesis and Hospital tenders
  • Agency representation & non-commercial sponsorship
  • Product sponsorship transfers
  • Artwork, PI and CMI management
  • Promotional advertising review
  • Dossier management
  • Full Regulatory Information Systems management

Specialist 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