Regulatory Expertise, Built for GI Trials
GI programs demand early alignment. Our regulatory experts work in concert with our clinical trial design , clinical study management, and data teams to ensure filings precisely reflect how the study will be run.
End-to-End Regulatory Strategy Support
We take on the planning and coordination that keeps your trial moving, including:
Pathways and strategy
We identify required authorizations and define country-specific regulatory strategies to accelerate activation (deep expertise in European [EU] processes)
Dossier planning
Detailed planning via our global regulatory tracker and submission plan establishes exactly what needs to be done, who does it, and when
Document preparation and quality control (QC)
Authoring and QC for investigator’s brochures (IB), protocols, informed consent forms (ICF), IMPDs, and safety documentation
Labeling and logistics
Coordination of label regulatory reviews, translations, and import/export requirements for investigational products
Continuous maintenance
Complete study life cycle management to ensure compliance from start to finish: amendments, notifications, progress reports, and result submissions
Submissions and Interactions
We manage the entire submission process, keeping you aligned with local and regional requirements:
Applications
Investigational new drug (IND), clinical trial application (CTA), EU Clinical Trial Information System (CTIS) applications, and local equivalents
Ethics
Coordination of institutional review board (IRB) and independent ethics committee (IEC) submissions
Agency meetings
Preparation of briefing books, minutes, and action logs for pre-IND and scientific advice meetings
Safety reporting
Expedited reports and development safety update reports (DSURs) that align with the study safety plan
Country Startup
From ethics, regulatory, and translations to vendor setup and training, we streamline startup across countries and work streams so sites open earlier. We monitor regulatory risks with site management and risk-based monitoring plans, keeping status visible at every stage.
