Regulatory Operations and Submissions Support
Optimizing and streamlining the regulatory submission process
Boyds’ regulatory operations and publishing team streamlines the end-to-end submissions process, providing trusted global expertise to help partners navigate the complex regulatory landscape. We ensure every document meets the highest technical and compliance standards required by global health authorities.
What is Regulatory Operations?
Regulatory Operations is the function responsible for managing and delivering the end-to-end regulatory submissions process. This includes planning, coordinating, formatting and technically compiling the documentation required by global health authorities.
The team also plays a critical role in ensuring that every submission meets strict regulatory, technical and quality standards, helping companies bring medicines to market efficiently and compliantly.
Regulatory Operations Framework
We support you throughout the entire submission lifecycle, from creating and preparing documents to publishing, reviewing, submitting, and securely archiving your dossier, ensuring a smooth, compliant, and efficient process from start to finish.
Your trusted partner for global regulatory submissions
At Boyds, our dedicated Regulatory Operations (Reg Ops) group consists of highly driven, experienced professionals who provide seamless support throughout the end-to-end regulatory submissions process, including regulatory publishing and eCTD submissions.
We support you in planning and preparing submissions that align with global regulatory expectations and the specific requirements of each submission pathway.
Regulatory Publishing is a dynamic, flexible process tailored to each client and project. It involves cross-functional collaboration, content preparation, harmonisation, version control, compliance validation and real-time eCTD submission tracking. Our proven process enhances every step, bringing technical accuracy, efficiency and global regulatory compliance.
With increasing regulatory complexity, choosing the right Reg Ops partner is essential for meeting non-negotiable deadlines. Our team thrives on challenges and understands the importance of offering personalised and flexible solutions.
Regulatory Operations
Our experienced Regulatory Operations team provides seamless support throughout the end-to-end regulatory submissions process for biotech and pharma companies.
Regulatory Publishing
Regulatory Publishing extends far beyond formatting. We manage harmonisation, version control, compliance validation and real-time tracking to support accurate, compliant submissions.
eCTD Submissions
We prepare, publish, validate and dispatch eCTD submissions in line with global regulatory requirements, ensuring accuracy, consistency and full technical compliance.
Boyds' Regulatory Operations Services
Surveillance of Regulatory Requirements
Global regulatory landscapes continually evolve, so staying compliant is essential to avoid delays or rejections of eCTD submissions. Our Regulatory Operations team continuously monitors and adapts to the latest technical requirements from global health authorities.
We ensure your submissions remain aligned with:
• Current regional eCTD specifications and validation criteria
• Updated ICH guidance and regional implementation guides
• Authority-specific metadata, structure and format requirements
• Technical changes such as platform and version upgrades (e.g., eCTD v3.2.2 → v4.0)
Submissions Management
Efficient regulatory submission management is the backbone of successful global filings. Our team provides end-to-end oversight and co-ordination — from planning to dispatch — ensuring accuracy, compliance and on-time delivery.
We manage all aspects of submission execution, including:
• Submission strategy aligned with regulatory milestones
• Cross-functional co-ordination
• Content and document tracking
• Detailed submission planning and project management
• Quality control and compliance checks before publishing
Compliant Document Preparation
High-quality documents are essential for successful eCTD publishing. We ensure all documents meet strict technical and formatting requirements.
We prepare eCTD-compliant documents that are:
• Accurately formatted to global and regional specifications
• Fully navigable to support efficient regulator review
• Validated against technical specifications and style guides
• Quality-controlled for consistency and completeness
eCTD Publishing & Validation
Our experts ensure all eCTD submissions are structured, navigable and valid.
Our experience includes:
• NDAs, BLAs, ANDAs and amendments
• IND applications and amendments
• MAAs, responses and post-marketing submissions
• NDS filings and responses
We also support pre-clinical and clinical document formatting, including:
• IMPDs
• Briefing books and briefing packages
Electronic Submission Dispatch
We ensure secure and timely dispatch of submissions through validated global electronic platforms.
This includes:
• Submission via validated electronic gateways
• Monitoring acknowledgements, validation reports and technical feedback
• Issue resolution and technical support
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
Looking for more Regulatory Support?
Ready to prepare or publish your next regulatory submission?
Speak to our Regulatory Operations & Publishing team.
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.