A New Regulatory Era
The FDA Modernization Act 3.0 represents a fundamental shift in drug development, removing the animal testing mandate and officially recognizing New Approach Methodologies (NAMs) as valid alternatives. Our platform is built from the ground up to generate regulatory-ready data aligned with this new paradigm.
FDA Modernization Act 3.0 Key Points
- Removes requirement for animal testing before human trials
- Explicitly authorizes use of NAMs (organ-on-chip, organoids, computational models)
- Requires FDA to accept NAMs data when scientifically appropriate
- Enables faster, more human-relevant drug development pathways
Regulatory Framework Support
FDA MAA 3.0
Full compliance with FDA Modernization Act requirements for NAMs-based submissions, including data format, validation, and documentation standards.
ICH Guidelines
Alignment with ICH S5 (reproductive toxicity), S7 (safety pharmacology), and M7 (mutagenicity) guidelines for harmonized global submissions.
EMA 3Rs
Support for European Medicines Agency 3Rs principles (Replacement, Reduction, Refinement) and acceptance of alternative methods.
OECD Test Guidelines
Compliance with evolving OECD guidelines for in vitro testing methods, defined approaches, and integrated testing strategies.
Built-In Compliance
Audit Trails
Complete, immutable records of all data generation, processing, and analysis steps meeting 21 CFR Part 11 requirements.
Validation Packages
Pre-built IQ/OQ/PQ documentation, reference compound benchmarking, and method validation protocols.
CDISC Standards
Native export to SEND (nonclinical) and SDTM (clinical) formats for direct regulatory submission integration.
Data Security
SOC 2 Type II certified infrastructure with encryption at rest and in transit, role-based access control, and HIPAA compliance.
Regulatory Submission Support
Study Reports
Automated generation of GLP-style study reports formatted for IND/NDA/BLA submissions.
Method Qualification
Documentation packages demonstrating fit-for-purpose qualification of NAMs assays.
Regulatory Strategy
Expert consultation on integrating NAMs data into regulatory submission strategies.
Agency Meetings
Support materials for pre-IND meetings and regulatory agency discussions about NAMs approaches.