Driving drug development with precision and expertise
Safety assessment services
Overview
Your Trusted Partner in Safety Assessment for Drug Development
We drive pharmaceutical innovation by offering comprehensive safety assessment services tailored to meet the highest global regulatory standards. With GLP-certified and AAALAC-accredited facilities, a team of experienced scientists, and cutting-edge technologies, we provide reliable data and insights to optimize your drug development journey.
We strive to empower pharmaceutical companies with confidence and clarity in making informed decisions about their 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.
Advanced Pathology Services
Specialized pathology testing to ensure drug safety and efficacy
Medicilon’s pathology team supports safety assessments with specialized tools and expertise.
- Tissue Cross-Reaction (TCR) Tests
- Immunohistochemistry (IHC)
- Histopathological Examinations
- Clinical Pathology
Why choose Medicilon for
Safety Assessment Services?
GLP-Certified & AAALAC-Accredited Facilities
We adhere to international standards, ensuring the reliability and regulatory compliance of every study.
Expert Team
Our scientists, with decades of experience, deliver tailored solutions that address the unique needs of your project.
State-of-the-Art Infrastructure
Our advanced facilities span over 300,000 sq ft of GLP-certified laboratory space, equipped with the latest tools and specialized resources to ensure accurate and reliable safety. reliability.
End-to-End Support
From initial study design to comprehensive data analysis, we provide seamless collaboration to ensure timely and accurate results.
Specialized safety evaluations
Medicilon’s regulatory experts streamline the complex approval process, ensuring global compliance.
- Inhalation Formulation Safety Precise assessments for inhaled drug formulations.
- Ophthalmology Safety Specialized testing to evaluate the safety and efficacy of ophthalmic drugs.
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.
