Regulatory Operations and Publishing
Boyds’ in-house regulatory operations and publishing service optimizes and streamlines the submission process, helping to bring new medicinal products to patients who need them.
Navigating a complex regulatory landscape
Regulatory operations play a crucial role in facilitating partners navigating the complex regulatory landscape, ensuring products meet the essential standards of technical quality while adhering to the stringent regulations and requirements set by global health authorities.
Our expertise
At Boyds, our dedicated regulatory operations group consists of highly driven, experienced professionals who provide seamless support throughout the end-to-end regulatory submission process.
We manage the planning, coordination and execution of global regulatory submissions, ensuring precision, compliance and accelerated delivery for biotech and pharma companies.
The publishing process
Regulatory publishing goes far beyond just formatting documents.
It is a dynamic, flexible process, tailored to each client and project, involving cross-functional collaboration, content creation and harmonisation, version control, compliance validation, and real-time submission tracking.
Our proven approach and experience enhance every step, bringing technical accuracy, efficiency, and full global regulatory compliance.
Why it matters
With regulatory requirements becoming increasingly complex, having the right regulatory operations partner is critical to meeting non-negotiable deadlines. Our team thrives on challenges and knows the importance of offering a personalised and flexible solution.
Let’s work together
Boyds can deliver your regulatory submissions with expertise and care.
Let’s work together to streamline your submissions and accelerate your path to market. Speak with an expert today.
Our regulatory operations team equips you with the expertise and services essential for seamless submissions:
- Surveillance of agency technical requirements for continued compliance
- Submissions management
- Submission-ready documents
- eCTD compilation, publishing and technical validation
- Electronic gateway submission dispatch
Industry-leading software platform
Boyds has invested in the industry-leading regulatory information management system, LORENZ docuBridge, to enable full electronic submission, publishing, and regulatory document management.
Foreseeing potential hurdles
Our team of expert regulatory operations specialists can draw on their expertise and experience to anticipate potential challenges and hurdles, helping to mitigate the risks of costly delays. Working with the wider regulatory affairs team, we are able to drive greater efficiencies across the authoring, review, and submission steps of the process.
Success stories
Expert and swift publishing support for an urgent EU Marketing Authorization Application
Boyds was approached by a biotech to manage the publishing of an EU Marketing Authorization Application (MAA) Submission for a new medicinal product in a very short turn around.
Contact our regulatory operations team today 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.