Regulatory Expertise That Accelerates Approvals
From study design through submission, our regulatory affairs team ensures every protocol, data set, and report aligns with the requirements of your target agencies. Deep knowledge of global regulatory frameworks means fewer deficiency letters, faster reviews, and predictable timelines.
Built Around Compliance, Driven by Science
Every study conducted at Meramec Bio Eval Center is designed within a comprehensive regulatory framework that accounts for the specific submission requirements of your target markets. Our team maintains current expertise across FDA, USDA, EPA, EMA, PMDA, and other international authorities, translating complex guideline requirements into actionable study protocols.
This regulatory-first approach eliminates the costly rework and supplemental studies that result from misaligned protocols. Whether you are preparing an IND application, seeking veterinary product approval, or registering an agrochemical formulation, our regulatory affairs scientists work alongside your team from day one to build a clear, efficient path to market authorization.
Regulatory Frameworks We Navigate
Our studies are designed and executed to meet the specific requirements of major regulatory agencies and international guideline bodies.
Food & Drug Administration
Full compliance with FDA 21 CFR Part 58. Protocols satisfy CDER, CBER, CVM, and CDRH requirements for IND, NDA, NADA, and PMA submissions.
U.S. Department of Agriculture
USDA-registered facility under the Animal Welfare Act. Full IACUC oversight, regular inspections, and USDA-CVB licensing support.
Environmental Protection Agency
EPA FIFRA and TSCA compliance for agrochemical and industrial chemical safety evaluation per OPPTS harmonized test guidelines.
OECD Test Guidelines
Internationally accepted test guidelines enabling mutual data acceptance across 30+ OECD member countries. TGs 401–453.
Good Laboratory Practice
Comprehensive GLP quality system per FDA 21 CFR Part 58 and OECD Principles. Dedicated QA oversight and complete traceability.
ICH Harmonized Guidelines
ICH Safety (S), Efficacy (E), and Multidisciplinary (M) guidelines. S1–S11 for toxicology, M3(R2) for clinical timing.
The Regulatory Process
Our structured approach ensures regulatory alignment at every stage, from initial scoping through agency submission.
Initial Consultation
Understand your compound, target indication, and regulatory submission objectives. Identify applicable guidelines and assess data gaps from prior studies.
Study Design
Develop GLP-compliant protocols addressing species selection, dose design, endpoints, duration, and statistical methodology — tailored to your target agencies.
Protocol Review
Internal QA review for GLP compliance and guideline adherence. Collaborative finalization with your regulatory and scientific teams.
Study Execution
Full GLP conditions with comprehensive documentation, real-time data capture, and scheduled QA inspections. Ongoing sponsor communication throughout.
Data Analysis
Rigorous statistical analysis, pathology peer review, and systematic data verification. Results cross-referenced against historical control data.
Report Generation
GLP study reports drafted, reviewed by Study Director, and QA-audited. Complete data tables, individual animal data, and pathology narratives included.
Submission Support
Compile submission-ready data packages, prepare Module 4 nonclinical documentation, and draft agency correspondence. Support through the review process.
GLP Compliance Standards
Our GLP quality system provides the foundation for every study we conduct. These standards ensure data integrity, reproducibility, and full regulatory acceptance.
- ✓ Dedicated Quality Assurance Unit independent of study conduct, performing scheduled inspections and critical-phase audits
- ✓ Comprehensive standard operating procedures covering facility operations, animal husbandry, test article handling, and data management
- ✓ Validated and calibrated analytical equipment with documented maintenance schedules and performance verification
- ✓ Secure data management systems with full audit trails, electronic signatures, and 21 CFR Part 11 compliance
- ✓ Controlled test article receipt, storage, characterization, and accountability with documented chain of custody
- ✓ Study Director oversight with documented protocol amendments, deviations, and corrective actions
- ✓ Environmental monitoring of animal rooms, storage areas, and laboratory spaces with documented records
- ✓ Personnel training and qualification documentation with competency assessments
- ✓ Secure, climate-controlled archive storage of raw data, specimens, protocols, and final reports
- ✓ Regular management reviews and internal audits for continuous compliance improvement