Accelerating your oncology product launch

Project Orbis represents a major milestone in regulatory collaboration across jurisdictions. Today, Project Orbis goes beyond the US FDA, and includes Australia, Brazil, Canada, Singapore, Switzerland and the UK.

The key advantage of Project Orbis is faster patient access to innovative cancer therapies across multiple countries by shortened timelines from submission to approval. This is achieved via a coordinated, collaborative agency review on basis of common dossiers, shared evaluation questions and applicant responses that avoid multiplications of regulatory efforts.

Project Orbis has the potential to save hundreds of thousands in pure cost and allow significantly faster uptake across multiple markets.

View our Webinar: Project Orbis - What you need to know, for a comprehensive introduction to the initiative.

A new host of challenges

Importantly, Project Orbis is not a regulatory route that can be chosen, selection is at the FDA’s discretion and is based on your product’s innovative and significant clinical attributes. Should you get selected it will be up to you to step up to the challenge, but if you do, you must act quickly!

Once you have been selected for Project Orbis, you have less than a month to decide whether you are able to handle the simultaneous submissions in multiple countries. This requires a prompt reply and foresightful planning to ensure that you have enough resources at your disposal. This puts a whole new host of challenges on your regulatory team.

Conducting multiple regulatory filings in parallel which require local regulatory knowledge and contacts in each chosen country, can be an insurmountable effort, especially if you were not prepared for the opportunity, to begin with. Building up a team or bringing in external resources takes time – time that you will not have. This is where we can step in!

Stepping up to the challenge

At NDA we know what it takes to seize the opportunities that Project Orbis offers, flawlessly and efficiently. Ever since the introduction of the initiative, NDA has followed, and been a part of the development, working as our clients’ extended team to deliver multiple parallel submissions successfully to the agencies.

Through our presence in several of the key markets and our collaborator network which extends to all the Orbis jurisdictions, as well as our expertise in oncology and regulatory project management, we provide a team that instantly and seamlessly integrates with your activities and carries the day.

When the FDA offers you the opportunity, NDA delivers you success.

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Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

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