Regulatory in vitro Toxicology
Regulatory in vitro Toxicology Services
With more than 20 years of safety assessment experience, Pharmaron delivers regulatory in vitro toxicology services that generate high-quality data aligned with regulatory expectations. We provide our clients with reliable timelines and both non-GLP and GLP-compliant deliverables.
Our in vitro toxicology services cover a wide range of modalities including small molecules, large molecules, biologics, as well as cell and gene therapies.
Regulatory-Compliant in vitro Toxicology
Performed in our GLP-compliant facilities, our regulatory in vitro toxicology assays align with ICH and OECD guidelines and are delivered with the documentation regulators expect for file submissions. Our facilities are routinely inspected by regulatory authorities, for example, the FDA, OECD, NMPA, and MHRA. With a long track record of supporting IND‑enabling safety packages, we provide not only compliant data, but also scientific interpretation to help clients make confident development decisions.
Capabilities
New Approach Methodologies (NAMs): Modern in vitro Toxicology Strategies
Pharmaron integrates NAMs to increase human relevance and minimize animal use wherever possible. We offer innovative, translational models, such as organoids and organ‑on‑chip models, which you can explore on our Organ-Specific in vitro Toxicity webpage. Our physiological models help generate mechanistic data to help predict human responses that go hand-in-hand with traditional assays and strengthen regulatory submissions.
Integrated in vitro and in vivo Toxicology Workflows
Pharmaron’s in vitro toxicology services are available as standalone studies or integrated with in vivo Safety Assessment. Choosing a single CRO minimizes hand‑offs, accelerates timelines, and provides seamless regulatory documentation.
Screening for discovery-stage programs is available at Pharmaron supported by our biology and ADMET teams, please view our in vitro Toxicity Services for Drug Discovery.
Cardiovascular Toxicology Service
Pharmaron provides a comprehensive portfolio of in vitro cardiovascular toxicology assays to support regulatory submission as part of our safety pharmacology offering.
Pharmaron’s Cardiovascular Toxicology Capabilities:
- ICH S7B, ICH S7B Q&A: hERG assay (GLP and non-GLP)
- Multi‑ion channel panel assays (CiPA)
- Human iPSC‑derived cardiomyocyte electrophysiology (MEA)
Beyond classical S7B assays, Pharmaron also offers advanced 3D cardiac spheroids and heart organoids for mechanistic assessment of structural and functional cardiovascular toxicology. Explore our Organ‑Specific in vitro Toxicology capabilities.
In vitro Genotoxicity Service
Pharmaron provides a full suite of in vitro genotoxicity assays to detect mutations and damage to chromosomes in line with ICH S2(R1) recommendations.
We perform around 2,000 in vitro genotoxicity non-GLP projects per year with turnaround times of 5 days (Ames test). About 300 GLP-compliant in vitro genotoxicity studies are performed annually by Pharmaron to support IND applications.
Where follow-up is required based on in vitro findings, Pharmaron also supports in vivo genotoxicity studies. Learn more about our Genetic Toxicology offering.
Pharmaron’s Regulatory in vitro Genotoxicity Testing Services:
- OECD TG 471: Bacterial reverse mutation test including Micro Ames, Mini Ames, Enhanced and Standard Ames
- OECD TG 487: In vitro Micronucleus Test (MNT) to identify chromosome breakage or loss, with the option of a follow up chromosomal rearrangement extended stability test
- OECD TG 473: In vitro Chromosomal Aberration Test (optional/legacy) to evaluate structural chromosome damage
- OECD TG 490: In vitro Mouse Lymphoma Assay (MLA) to detect gene mutations and chromosomal damage
- OECD TG 475: In vivo Mammalian Bone Marrow Chromosomal Aberration
- OECD TG 489: In vivo Mammalian Alkaline Comet Assay to detect DNA damage
- ICH M7(R2): Impurities assessment to evaluate and qualify mutagenic impurities in DS/DP
Phototoxicity and Skin Toxicology Assays
Pharmaron offers a robust set of assays to help identify photo-reactive compounds and assess their toxic potential.
Phototoxicity Testing Capabilities
- OECD TG 432: 3T3 NRU phototoxicity test (GLP and non-GLP)
- FDA ICH S10: Photosafety evaluation package including 3T3 NRU phototoxicity test and in vivo skin phototoxicity (GLP and non-GLP)
- Light-absorption: MEC determination (non-GLP)
- Photoreactivity: ROS determination (non-GLP)
For skin toxicology we support non-GLP 3D in vitro assays for skin irritation and corrosion within our Organ-Specific in vitro Toxicity portfolio.
In vitro Immunotoxicology Service
Pharmaron’s in vitro immunotoxicology assays follow regulatory guidelines where applicable, ensuring methods align with authority expectations for biologics, cell- and gene therapeutics, and therapeutic proteins.
Pharmaron’s Immunotoxicology Risk Assessment Capabilities:
- Immunogenicity
- Immunophenotyping
- Cytokine assays
- Innate immune activation
- Complement activation
- Tissue cross-reactivity
For immunotoxicology screening assays that support candidate prioritization before formal IND‑enabling studies, please visit our DiscoveryIn Vitro Toxicology webpage.
Metabolism-Based in vitro Toxicology Services
Pharmaron offers testing of toxicities related to how a drug is absorbed, distributed, metabolized, and excreted, which are critical to predicting safety of new compounds. Several metabolism-based in vitro toxicology studies are expected by regulators to de-risk first-in-human studies.
Pharmaron also supports regulatory biowaiver strategies with BCS‑aligned in vitro assays that can justify the waiving of certain in vivo studies and streamline early development.
Our in vitro toxicology services identify typical toxicities driven by metabolism and transport, such as:
- ICH M3 MIST: Detection of reactive, toxic or human-unique metabolites
- ICH M12: Drug-drug interaction
- Transporter interaction
- Impaired clearance and liver toxicity
- PBPK modeling to bridge between in vitro assays and human risk prediction
Learn more about our metabolism and transporter-based toxicity capabilities on our Regulatory in vitro ADMET webpage.
