Driving drug development with precision and expertise
Safety assessment services
Overview
Your Trusted Partner in Safety Assessment for Drug Development
At Medicilon, we partner with pharmaceutical and biotech companies to streamline the path from discovery to IND submission through our comprehensive GLP and non-GLP toxicology services. With GLP-certified, AAALAC-accredited facilities, a team of seasoned scientists, and advanced technologies, we deliver high-quality safety assessment data that meets the most rigorous global regulatory standards.
Our deep regulatory expertise and commitment to data integrity ensure smooth study execution-empowering you with the confidence and clarity to make informed decisions about your drug candidates’ safety and efficacy.
Core services
Comprehensive safety assessment for drug development
Medicilon provides non-GLP and GLP safety assessments tailored to your drug development needs. Whether for early research or regulatory submission, our precise solutions support every stage of your project.
Toxicology Studies
Our Non-GLP & GLP Toxicology Studies services are designed to evaluate safety profiles in diverse models with unparalleled precision.
Single and Multiple Dose Toxicity Studies
Assess potential adverse effects in rodent and non-rodent models.
Local Toxicity Studies
Ensure site-specific tolerance at the drug administration site.
Toxicokinetic Studies
Deliver complete insights into absorption, distribution, metabolism, and excretion (ADME) to inform pharmacokinetics.
Safety pharmacology
Through advanced methodologies, we analyze the impact of drug candidates on key physiological systems.
Our Non-GLP studies support early-phase research by identifying potential risks, while GLP-compliant studies ensure regulatory adherence for submission and approval. This dual approach enables both exploratory assessments and comprehensive safety evaluations.
Key systems assessed
- Central Nervous System
- Cardiovascular System
- Respiratory System
Genotoxicity studies
We assess the genetic safety of compounds using industry-standard tests. Our Non-GLP studies provide early risk identification, while GLP-compliant studies meet regulatory requirements for submission.
Testing methods
- Ames Test – Detects mutagenic potential in bacteria.
- Chromosomal Aberration Test – Identifies structural changes in chromosomes.
- Micronucleus Test – Evaluates chromosome damage in cells.
Immunogenicity studies
Medicilon’s immunogenicity studies assess potential immune responses to drug candidates, ensuring both safety and efficacy for clinical applications. Our Non-GLP studies support early-phase risk assessment, while GLP-compliant studies provide validated data for regulatory submissions.
Reproductive toxicity studies
We evaluate the effects of compounds on mammalian reproduction and embryonic development across all study stages. Our Non-GLP studies aid early risk identification, while GLP-compliant studies ensure regulatory adherence for comprehensive safety assessment.
International Quality & Regulatory Compliance
Our GLP-compliant studies adhere to international regulatory requirements
Our experienced study directors and project managers coordinate all aspects of toxicology studies, from in-life testing to data analysis. This reduces complexity, minimizes delays, and accelerates IND filing timelines.
- GLP-certified and AAALAC-accredited facilities
- Successful track record with FDA and NMPA GLP inspections
- SEND-compliant data management using Instem's submit™ platform
- OECD and ICH regulatory compliance
Study Design & Protocol Development
Strategic Approach: Non-GLP and GLP Toxicology for IND Success
Medicilon provides customized study designs aligned with FDA and NMPA guidelines, including:
- Dose selection strategies, animal models, and study endpoints
- Specialized assessments such as inhalation, ophthalmic, and immunogenicity studies
Toxicology Execution
- Non-GLP range-finding studies to determine safety thresholds
- Definitive GLP toxicology studies for pivotal assessments
- Integrated toxicokinetic analysis for comprehensive safety profiling
Data Analysis & Regulatory Reporting
- Detailed, regulatory-compliant study reports
- Robust quality assurance with on-site inspections and audits
- SEND-compatible datasets for seamless IND submission
IND Submission Support
- Compilation of pivotal study reports and regulatory documentation
- Expert regulatory consultation to address FDA and NMPA queries
IND-Ready: eCTD Modules & SEND Compliance
The electronic Common Technical Document (eCTD) is the standard format for IND filings required by the FDA (Reference Link) and global regulators. It consists of five key modules:
Regional Information
Administrative documents specific to the region, including forms, cover letters, and product labeling.
Quality Information (CMC)
Detailed data on drug substance and product manufacturing, controls, and quality.
Clinical Study Reports
Comprehensive results and data from human clinical trials.
CTD Summaries
High-level overviews of nonclinical and clinical data to support regulatory review.
Nonclinical Study Reports
Full toxicology and pharmacology study reports from animal testing.
SEND Compliance Matters
The FDA mandates nonclinical studies to be submitted in SEND format, which:
- Standardizes data structure for easier regulatory review
- Reduces errors in large datasets
- Speeds up the IND assessment process
Our bioinformatics team leverages Instem’s submit™ platform to generate SEND-compliant datasets while compiling all documentation into an eCTD-ready format, ensuring:
- Organized and FDA-compliant submissions
- Ophthalmology Safety
- Faster and smoother IND approval
Proven Success
Medicilon’s IND-Focused Toxicology Case Studies
Explore how Medicilon’s IND-focused toxicology studies have helped clients overcome regulatory hurdles, accelerate timelines, and advance drug candidates with confidence. Each case highlights our scientific expertise and strategic approach to IND success.
Genotoxicity Testing for IND Approval
A pharmaceutical sponsor required genotoxicity assays for a small molecule. Medicilon conducted:
- Ames test
- In vitro chromosomal aberration assay
- In vivo micronucleus test in rats
Results: No genotoxicity detected, leading to a successful IND filing.
Toxicology for Small Molecule IND Submission
A company developing a liver disease treatment needed repeat-dose toxicology studies. Medicilon performed:
- Dose-range-finding (DRF) studies
- 28-day GLP toxicology studies in rats and dogs
- Toxicokinetic assessments
Outcome: Established a safe starting dose for Phase I clinical trials.
Why work with Medicilon for your Safety Assessment Service needs
Medicilon delivers fast, reliable IND-focused toxicology services backed by global regulatory expertise, advanced facilities, and end-to-end support, from study design to SEND-ready eCTD submissions. Our proven track record with FDA and NMPA approvals helps pharmaceutical and biotech companies accelerate timelines and move drug candidates forward with confidence.
Proven Regulatory Success
Extensive experience with FDA, NMPA, and OECD inspections
Fast Turnaround
Large-scale facilities enable accelerated study timelines
Expert Consultation
Toxicologists and regulatory specialists guide study execution
End-to-End Services
From non-GLP pilot studies to final IND submission support
Partner with Medicilon for your next breakthrough
Medicilon’s comprehensive safety assessment services offer more than just data, they provide a pathway to innovation and compliance. Whether you are developing small molecules or biologics, we ensure safety, precision, and compliance at every step of your drug development process.
