Regulatory Operations Services
Our Regulatory Operations team delivers regulatory success by providing comprehensive, compliant and timely services.
Surveillance of Regulatory Requirements
Global regulatory landscapes continually evolve, so staying compliant is key to avoiding delays or rejections to eCTD submissions. Our Regulatory Operations team continuously monitors and adapts to the latest technical requirements from global health authorities.
We ensure your submissions are always aligned with:
- Current regional eCTD specifications and validation criteria
- Updated ICH guidance and regional implementation guides
- Authority-specific requirements for metadata, structure and file formats
- Technical changes such as version upgrades (eCTD v3.2.2 to v4.0)
Submissions Management
Efficient submission management is the backbone of successful regulatory filings. Our Regulatory Operations team provides end-to-end oversight and coordination of your regulatory submissions – from planning to dispatch – ensuring accuracy, compliance and on-time delivery
We manage all aspects of submission planning and execution, including:
- Submission strategy alignment with regulatory timeline and milestones
- Co-ordination across cross-functional teams
- Content tracking and document tracking
- Detailed submission planning and project management
- Quality control and compliance checks prior to publishing
Compliant Document Preparation
High-quality, submission-ready documents are essential for successful eCTD filings. Our Regulatory Operations team ensure all documents meet the strict technical and formatting requirements of global regulatory authorities.
We transform your source content into eCTD-compliant documents that are:
- Accurately formatted to global and regional specifications
- Have full navigational aids to facilitate review
- Are validated against technical specifications and style guides
- Quality controlled for consistency, completeness and compliance
eCTD Publishing and Validation
Our focus is quality. Our expert professionals ensure final packages are structured, navigational, and valid. Examples of our extensive experience are:
- New Drug Applications (NDA) and associated amendments
- Biologic Licence Applications (BLA) and associated amendments
- Abbreviated New Drug Applications (ANDAs) and amendments
- Investigational New Drug (IND) Applications and amendments
- Marketing Authorisation Applications (MAA), responses and all associated post-marketing applications from variations to Repeat Use Applications
- New Drug Submissions (NDS) and responses
- Pre-clinical and Clinical document formatting
- Investigational Medicinal Product Dossier (IMPD)
- Briefing books, briefing packages and briefing packs
Electronic Submission Dispatch
Boyds ensure secure and timely submissions through access to many global platforms:
- Submission through validated electronic gateways
- Monitoring and confirmation of receipts including acknowledgements, validation reports and technical feedback.
- Issue resolution and support
Get in touch with the regulatory operations team today to find out more about how we can help you with your regulatory submissions and publishing.
Get in touch with the regulatory operations team today to find out more about how we can help you with your regulatory 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.