Regulatory Affairs & Operations Services
Regulatory Strategy & Submissions
We help sponsors plan a clear regulatory path from early development through submission, so filings are built on a solid strategic foundation.
- Regulatory strategy planning and gap assessments for INDs, NDAs, BLAs, and international filings
- Preparation and compilation of submission-ready dossiers
- Coordination with biostatistics, medical writing, and clinical operations to align submission content and timelines
Publishing & Electronic Submissions
Once a dossier is ready, we manage its formatting and delivery so it meets each health authority's technical requirements.
- eCTD publishing and lifecycle management
- Formatting and hyperlinking of submission documents to agency specifications
- Quality control checks prior to submission to health authorities (FDA, EMA, and other global regulators)
Post-Approval & Lifecycle Management
Our support continues well after approval, keeping products compliant as regulations and product information evolve.
- Management of post-approval variations, renewals, and annual reports
- Labeling updates and change control coordination
- Ongoing regulatory intelligence to track evolving requirements across markets
Tools & Systems Expertise
Our regulatory team works across the systems sponsors rely on to manage submissions and documentation.
- Experience with regulatory information management (RIM) and electronic submission publishing systems
- Document management aligned with 21 CFR Part 11 and good documentation practices
- Support for archiving and retrieval of regulatory records