In-depth Regulatory Affairs support

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Our passionate and dedicated Regulatory Affairs team provides global advice and services to the pharmaceutical, medical device and healthcare industries. We are experienced regulatory professionals who can assist with bringing your product to market by providing regulatory advice and strategy throughout the drug development and marketing application processes.

Are you developing a medicine or medical device? We are here to help obtain high-quality registrations in short timeframes, so your product can benefit patients. We can provide you with strategic advice throughout the drug development process. Our global experts customise strategies to meet your needs across Medicines, Devices, Biologicals and anything in between.

Services include:

  • Development of clinical and product development plans
  • Design and co-ordination of non-clinical studies
  • Preparation of Regulatory applications, including IND, IDE, CTX, Orphan Drug Designations and Authorisation Applications
  • Agency interactions and scientific advice

GreenLight Clinical’s Regulatory Professionals work seamlessly with our Medical, Clinical and Business Development experts. This ensures the best possible outcome for your product development.

We help put the pieces together!

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 has the experts to 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

What To Expect

Our in-depth expertise, global footprint and investment in data & technology mean we can provide you with: