Regulatory Submission Pathways
Global collaborative and accelerated routes explained
Collaborative Submission Pathways
In an increasingly interconnected world, regulatory collaboration is essential to bring innovative therapies to patients with speed and efficiency. Two prominent work-sharing initiatives, Project Orbis and Access Consortium, are at the forefront of international regulatory cooperation.
Boyds’ regulatory operations team streamlines your submissions across multiple jurisdictions, leveraging Project Orbis and Access Consortium to reduce time, cost, and complexity.
Collaborative platforms like Project Orbis and the Access Consortium exemplify the shift toward global regulatory synergy.
By working together they:
- Enhance transparency and trust
- Leverage global expertise
- Avoid unnecessary delays
- Support public health priorities
As the demand for timely access to innovative health solutions grows, such models are key to navigating complex global regulatory environments while prioritizing patient needs.
Project Orbis
Provides a framework for concurrent submission and review of oncology products among international partners. It enables regulators from multiple countries to simultaneously assess marketing applications, facilitating faster access to life-saving cancer treatments worldwide.
Participating countries include:
- United States (FDA)
- Australia (TGA)
- Canada (Health Canada)
- Singapore (HSE)
- Switzerland (Swissmedic)
- United Kingdom (MHRA)
- Brazil (ANVISA)
Benefits:
- Accelerated patient access to innovative cancer therapies
- Reduced duplication of regulatory efforts
- Shared scientific expertise and resources
Access Consortium
Is a coalition of like-minded regulatory authorities working together to streamline the review of the medicines and medical devices. It promotes shared assessments while allowing each country to make independent regulatory decisions.
Key focus areas:
- Joint reviews of new active substances and generics
- Sharing best practices and regulatory intelligence
- Reducing burden on industry through harmonized requirements
Benefits:
- Improved efficiency of regulatory process
- Faster access to safe, effective and high-quality health products
- Enhanced international alignment on regulatory standards
Benefits of Submission Pathway applications
Working with Boyds, you can:
- Reduce the resource burden by maintaining submission readiness, ensuring proper eCTD formatting, and managing external hyperlinks
- Gain clear oversight of resources to support effective planning
- Align efforts around a single goal – submitting to multiple agencies within the same timeframe
Why choose Boyds?
- We have strong, proven processes, continually monitoring and refining our systems and frameworks to drive efficiency and improvement
- We turn challenges into plans. With decades of regulatory operations experience, our team anticipates both known and unexpected pitfalls and delivers structured solutions
- We connect the global dots, stay agile when plans change, and provide clear, tangible solutions
Contact our regulatory operations team to learn how we can support your submissions and publishing.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.