IRSG is a global regulatory science consultancy with 25+ years of expertise and 50+ successful IND submissions. We partner with life sciences organizations worldwide to navigate FDA, EMA, ICH, and international regulatory frameworks, from IND through approval and beyond.
IRSG combines deep FDA and global regulatory institutional knowledge with the agility of a boutique firm. We work as a true extension of your team across FDA, EMA, Health Canada, PMDA, and ICH frameworks, bringing precision, speed, and practical wisdom to every regulatory challenge, wherever your program takes you.
From Pre-IND through global market authorization, IRSG provides the regulatory intelligence to advance your program across FDA, EMA, ICH, Health Canada, PMDA, and beyond.
Comprehensive pre-IND planning, global regulatory strategy, FDA and EMA meeting requests, and submission management for biologics, drugs, and combination products across multiple jurisdictions.
Chemistry, manufacturing, and controls strategy. GMP gap assessments, inspection readiness, and manufacturing site compliance support.
Multi-jurisdictional regulatory strategy spanning FDA, EMA, Health Canada, PMDA, and ICH frameworks. Market authorization planning, agency meeting management, and global submission coordination.
GMP-aligned workforce training, regulatory affairs bootcamps, and Good Regulatory Practices programming for life sciences teams.
Authorized U.S. agent services for foreign sponsors. Complete sponsor-investigator IND management for academic and institutional clients.
RegPulse and BrexAI platforms delivering real-time FDA guidance tracking, regulatory intelligence, and AI-assisted submission support.
Regulatory science is not just about compliance. It is about building the bridge between scientific discovery and the patients who need it.
IRSG is building the next generation of regulatory intelligence platforms, purpose-built for life sciences professionals who need answers faster.
Real-time FDA guidance tracking and regulatory intelligence platform. Stay current on guidance documents, Federal Register notices, and policy updates across CDER, CBER, and CDRH.
SaaS platform for clinical investigator pre-qualification. Built on AACT clinical trial data, PI Pre-CHECK helps sponsors identify and vet investigators before site selection.
AI-assisted regulatory submission platform. Intelligent document review, gap analysis, and submission readiness scoring for IND and NDA programs.
Virtual GMP manufacturing simulation platform for workforce training. Built in partnership with the Holbrook BioHub to train the next generation of biomanufacturing professionals.
IRSG operates the Holbrook BioHub at 270 Centre Street, Unit E, Holbrook, Massachusetts, a first-of-its-kind biomanufacturing training and ecosystem facility serving early-stage life sciences companies and the next generation of manufacturing professionals.
Visit Holbrook BioHubIRSG provided exceptional IND submission support. Dr. Saunders' depth of FDA knowledge and responsiveness made a complex regulatory process feel manageable. We could not have moved this fast without her team.
The IRSG team brought a level of rigor and practical FDA experience that we simply couldn't find at larger firms. They function as a true extension of our internal regulatory team, and they deliver.
Dr. Saunders has an extraordinary ability to translate complex regulatory science into actionable strategy. Her FDA meeting preparation is second to none, thorough, precise, and deeply strategic.
Weekly regulatory intelligence published every Tuesday at 8:30am ET. Practical FDA guidance for life sciences professionals.
Understanding the 15-day and 7-day expedited safety reporting requirements under 21 CFR 312.32.
How to determine which designation is right for your program and when to apply.
A practitioner's guide to the three pillars of FDA Good Practice standards and how they apply at each development stage.
Whether you're preparing your first IND, navigating a complex FDA or EMA interaction, or building a multi-jurisdictional regulatory strategy from scratch, IRSG is ready to work alongside you, wherever your program needs to go.