Comprehensive Testing Services for Regulated Products
From preclinical toxicology through regulatory submission, Meramec Bio Eval Center provides the integrated testing capabilities your product development program requires. Every study is conducted under GLP conditions with full regulatory traceability.
Animal Testing Services
GLP-compliant in vivo studies across five species platforms with purpose-bred colonies, full veterinary oversight, and USDA-registered facilities. Our species capabilities are tailored to the specific regulatory requirements and biological endpoints of your product category.
Dogs
Purpose-bred beagle colony for dermal irritation and sensitization, oral toxicity (acute through chronic), ocular safety assessment, and behavioral/palatability evaluations. Full clinical pathology and histopathology support.
Cats
Dedicated feline colony for palatability testing and product acceptance studies, oral toxicity assessment, and dermal safety evaluations. Specialized in veterinary pharmaceutical and pet product development programs.
Rodents
Barrier-level rodent facility supporting chronic toxicity studies, carcinogenicity bioassays, reproductive and developmental toxicity, and genotoxicity assessments per ICH and OECD guidelines. Rat and mouse models available.
Poultry
Dedicated poultry research facility for feed additive efficacy and safety testing, vaccine efficacy and immunogenicity studies, tissue residue depletion, and growth performance trials in broilers and layers.
Livestock
200-head cattle facility with BSL-2 containment for vaccine challenge trials, growth promotion studies, target animal safety evaluations, and pharmacokinetic studies. Specialized handling and large-animal veterinary care.
Animal Welfare Standards
All animal studies conducted under IACUC-approved protocols with enrichment programs exceeding USDA requirements. The 3Rs framework (Replacement, Reduction, Refinement) is integrated into every study design.
Human Product Testing
Preclinical safety evaluation programs designed to support IND applications, NDA/BLA submissions, and international regulatory filings. Our study designs follow ICH, FDA, and EMA guidelines to generate globally accepted data packages.
Clinical Safety Assessment
Comprehensive preclinical safety evaluation including single-dose and repeat-dose toxicity studies, safety pharmacology (cardiovascular, respiratory, CNS), and immunotoxicology assessments per ICH S6-S10 guidelines.
Bioequivalence Studies
In vivo bioequivalence and comparative bioavailability studies supporting ANDA submissions for generic pharmaceuticals. Cross-over and parallel-group designs with full bioanalytical method validation.
Pharmacokinetics & ADME
Absorption, distribution, metabolism, and excretion studies using validated LC-MS/MS bioanalytical methods. Single-dose and multi-dose PK profiling, mass balance, tissue distribution, and plasma protein binding assessments.
Cosmetic Safety Testing
Comprehensive safety evaluation for cosmetics, personal care products, and consumer formulations. Our integrated study designs generate data packages accepted by FDA, EU Cosmetics Regulation, and PMDA for multi-market product launches.
Dermal Safety Assessment
Acute and repeat-dose dermal irritation studies per OECD TG 404 and TG 410. Primary skin irritation, cumulative irritation, and phototoxicity testing. Histopathological evaluation of dermal tissue for comprehensive safety characterization of topical formulations.
Sensitization Testing
Dermal sensitization evaluation per OECD TG 406 (Guinea Pig Maximization Test, Buehler Test) and TG 429 (Local Lymph Node Assay). Integrated strategies combining in vitro screening with confirmatory in vivo assessment when required by regulatory authorities.
Ocular Safety
Eye irritation and serious eye damage assessment per OECD TG 405. Evaluation of ophthalmic products, eye-area cosmetics, and formulations with splash exposure potential. Draize scoring with slit-lamp biomicroscopy and fluorescein staining for detailed corneal assessment.
Stability & Formulation Testing
Accelerated and real-time stability testing under ICH Q1A conditions. Physical, chemical, and microbiological stability assessment supporting shelf-life determination and product registration across multiple climate zones.
Pharmaceutical Testing
Preclinical development programs for human and veterinary pharmaceutical candidates. From early dose-range finding through IND-enabling toxicology, our study designs are built to satisfy FDA, USDA-CVM, EMA, and international regulatory requirements.
Preclinical Toxicology
IND-enabling toxicology studies in rodent and non-rodent species per ICH M3(R2). Single-dose, dose-range finding, and GLP repeat-dose studies from 14 days through 26 weeks. Toxicokinetic profiling integrated into all repeat-dose programs.
Dose-Ranging & MTD
Non-GLP dose-range finding and maximum tolerated dose studies to inform GLP study design. Rapid turnaround protocols with clinical observations, body weight, food consumption, and targeted clinical pathology to establish dose levels efficiently.
ADME & Pharmacokinetics
Comprehensive absorption, distribution, metabolism, and excretion characterization. Plasma PK profiling, tissue distribution, metabolite identification, mass balance, and in vitro metabolism studies using validated bioanalytical methods (LC-MS/MS).
Safety & Efficacy Studies
Comprehensive toxicology study portfolio covering the full spectrum of regulatory-required endpoints. All studies conducted under GLP conditions with board-certified pathology review and independent quality assurance oversight.
Acute Toxicity
Single-dose toxicity studies via oral, dermal, inhalation, and parenteral routes per OECD TG 401-405 and 420-436. Up-and-down procedure and fixed-dose methods to minimize animal usage while meeting regulatory data requirements.
Subchronic Toxicity
28-day and 90-day repeat-dose toxicity studies per OECD TG 407/408 (oral) and TG 410/411 (dermal). Complete clinical pathology, ophthalmology, gross pathology, and histopathological evaluation with peer-reviewed pathology reports.
Chronic Toxicity
6-month and 12-month chronic toxicity studies per ICH S4 and OECD TG 452. Long-duration studies with interim sacrifices, recovery groups, and comprehensive toxicokinetic profiling to establish exposure-response relationships.
Reproductive Toxicity
Full reproductive toxicology program per ICH S5(R3) including fertility and early embryonic development (Segment I), embryo-fetal development (Segment II), and pre/postnatal development (Segment III) studies.
Developmental Toxicity
Embryo-fetal development studies in rats and rabbits per OECD TG 414. Comprehensive fetal examination including skeletal and visceral evaluation. Dose-range finding studies to optimize GLP study design.
Carcinogenicity
Two-year carcinogenicity bioassays per ICH S1 and OECD TG 451/453. Combined chronic toxicity/carcinogenicity study designs to optimize timelines. Statistical analysis by board-certified toxicologic pathologists.
Regulatory Submission Support
Beyond generating data, we help you assemble it into submission-ready packages. Our regulatory affairs team has direct experience with FDA, USDA, EPA, EMA, and international authorities, ensuring your nonclinical data meets reviewer expectations the first time.
GLP Documentation
Complete GLP study reports per regulatory format requirements. Protocol development, raw data management, statistical analysis, individual animal data tabulations, and final reports with QA statements. Archival and retrieval services for regulatory inspection readiness.
- ✓ Protocol development & amendments
- ✓ Raw data management & audit trails
- ✓ Statistical analysis & reporting
- ✓ QA phase inspections & statements
Regulatory Strategy
Scientific and regulatory consulting to optimize your nonclinical development strategy. Pre-IND meeting preparation, study design optimization for multi-market submissions, and gap analysis for existing data packages. Guidance on species selection, study duration, and endpoint requirements.
- ✓ Pre-IND & pre-submission strategy
- ✓ Multi-market study design optimization
- ✓ Nonclinical data gap analysis
- ✓ Regulatory authority meeting support
Submission Packages
Compilation and formatting of nonclinical data sections for IND, NDA, BLA, ANDA, 510(k), PMA, and veterinary product submissions. eCTD-compatible formatting for Module 2.4 (Nonclinical Overview), Module 2.6 (Nonclinical Summaries), and Module 4 (Nonclinical Study Reports).
- ✓ eCTD Module 4 preparation
- ✓ Nonclinical overview & summaries
- ✓ Integrated safety assessment
- ✓ International submission formatting
From Consultation to Submission
Every engagement begins with a scientific consultation to understand your compound, development stage, target markets, and timeline. Here is how a typical program proceeds.
Scientific Consultation
We review your compound profile, development stage, and regulatory targets. Our team recommends the optimal study program, species, and endpoints for your specific submission requirements.
Protocol Design
A detailed study protocol is developed collaboratively with your team, reviewed by our QA unit, and approved by the Study Director. Amendments are managed with full documentation and audit trails.
Study Conduct
Studies are conducted under GLP conditions with real-time data collection, veterinary monitoring, and scheduled QA inspections. Your project manager provides regular status updates and interim data as available.
Reporting & Submission
Final reports include complete data tabulations, statistical analyses, pathology peer review, and QA statements. Data is formatted for direct inclusion in your regulatory submission package.