Company Category: Toxicology & Safety Assessment CRO

Novotech

Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.

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NONA BIOSCIENCES

Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models. | Nona Biosciences is a Boston-based Biotechnology company specialized in fully human antibody discovery. Harbour Mice®, our proprietary technology, are fully human transgenic mice platforms for either conventional fully human antibody (H2L2) or heavy chain only (HCAb) antibody discovery, engineering, and development. The HCAb platform produces human Vh single domain antibodies, providing multiple advantages for bispecific and multispecific antibody engineering | Nona Biosciences is a Boston-based Biotech company specialized in fully human therapeutic antibody technology. Our proprietary Harbour Mice® technology are fully human transgenic mice platforms for either conventional fully human antibody (H2L2) or heavy chain only (HCAb) antibody discovery, engineering, and development. The HCAb platform is fully optimized and clinically validated with global patented protection. Nona Biosciences can provide comprehensive antibody discovery services from Idea to IND, which range from Beacon® Single B Cell Cloning, display technology to functional screening, characterization, in vivo efficacy assessment, antibody engineering, and CMC for clinical candidate generation. | Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models. Nona Biosciences is a biotechnology company offering integrated solutions for antibody discovery and development. Leveraging our proprietary Harbour Mice® platforms, which generate fully human H2L2 and heavy chain-only antibodies (HCAbs), we enable a broad range of therapeutic formats with high developability and flexibility. Nona’s HCAbs are the first and only clinically validated, fully human heavy chain-only antibodies on the market, offering advantages such as low immunogenicity, high solubility, and strong biophysical properties. Our H2L2 Open Access Platform enables rapid entry into discovery, while Modalities-on-Demand™ provides tailored support for bispecifics, TCEs, and other next-generation modalities including ADCs, CAR-T, and mRNA-based therapies. With capabilities spanning immunization, screening, engineering, and IND-enabling services, Nona empowers partners to move efficiently from idea to IND with flexibility and confidence. Our platforms have supported more than 300 discovery programs and over 19 partner INDs through a variety of collaboration models.

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NJ Bio

NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs and other complex bioconjugates. We offer comprehensive solutions spanning discovery, development, characterization, optimization, and bioanalysis, complemented by robust in vitro and in vivo capabilities to support translational decision-making. We provide toxicology, pharmacology, PK, and immunology services to support safety assessment, efficacy profiling, and translational development of ADC and bioconjugate programs. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc. is a CRO/CDMO that provides high-quality integrated chemistry and biology services to clients mostly from the biotech and pharma sectors. Main service areas include antibody-drug conjugates, bioconjugation, and multistep organic synthesis. The company is headquartered in Princeton, New Jersey, with additional chemistry facilities in Bristol, Pennsylvania. NJ Bio’s facility in Princeton, NJ, occupies ~ 80,000 sq ft of laboratory and office space, with specialized laboratory suites for highly potent compound synthesis, bioconjugation, bioassays, and analytical studies. The facility is very well equipped with instrumentation required for ADC- and bioconjugation-related work. | NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs. We offer comprehensive solutions for ADC development, characterization, optimization, and bioanalysis. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc., is a CRO that provides high-quality integrated chemistry and biology services for ADCs, bioconjugates and nucleic acid-based therapeutics. We strive to be a beacon of excellence in contract research, development and manufacturing by providing cutting-edge biopharmaceutical and advanced chemistry services. Backed by deep expertise in bioconjugation & chemical synthesis, we add value to targeted therapeutic programs through integrated services in conjugation, process development, characterization, and bioanalysis of complex molecules.

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MediTox s. r. o.

MediTox s.r.o. is GLP-certified CRO dealing with preclinical R&D comprehensive preclinical and toxicological program for human/veterinary products (EMA, ICH/VICH, FDA), medical devices (ISO 10993), chemicals and agrochemicals (OECD TG), development of animal models of selected human diseases. Contract research activities are pointed to general toxicology and pharmacology (acute toxicity, long-term toxicity, immunogenicity, safety pharmacology, toxicokinetics, Proof-of-Concept), genetic toxicology (genotoxicity and mutagenicity in vitro and in vivo), biocompatibility of medical devices (local and systemic toxicity, implantation), safety assessment of vaccines, etc. The members of the toxicological team have experience with practically all species including NHP, dogs, ferrets, cats and pigs and various kinds of compounds and indications. Common and special ways of administration are available as well as GLP-compliant platform for bioanalyses, clinical pathology and histopathology. Undisputed advantages are an approval for handling GMO, experience with variety of compounds and therapeutic areas and in preclinical toxicology in non-rodent species, particularly in mini pig, ferret and dog models. C.I.R. accreditation was renewed for 2024 – 2026 OLAW (US National Institutes of Health) approval for 2020 – 2025 | MediTox s.r.o., a long established and fully GLP compliant, preclinical CRO, has been providing safety/efficacy evaluation for nearly 25 years: – non-clinical studies supporting phase I – III CT (exploratory & regulatory studies) – strong expertise in non-rodent toxicology – BEQ/BA/PK/TK studies – medical device (ISO 10993), small molecules, vaccines, biotech derived drugs, veterinary drugs, … (EMA/ICH/WICH/OECD/FDA) – influenza, chronic glaucoma, arthrosis, contact dermatitis models available – revision of study documentation (plan, data, report) MediTox s.r.o. provides specific services in multiples species, customized procedures, and tailored solutions. | x

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Medicilon USA Corp

Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. From drug discovery, pharmaceutical research to preclinical research, Medicilon has supported more than 2000 client R&D programs worldwide resulting in 520 IND filings. With proven scientific excellence and FDA-aligned methodologies, we help biotech and pharmaceutical innovators fast-track their path from discovery to IND success. | Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. Medicilon has 21 years experience in the industry and has supported more than 2000 client R&D programs worldwide resulting in 580 IND filings. The company has over 441,320 ft2 of chemistry labs with > 1300 chemists located at three different sites. With operations in the USA, China, and Europe, Medicilon is a leading CRO offering integrated pharmaceutical R&D services, including DMPK/PD, toxicology (GLP and non-GLP), chemistry, discovery biology, and CMC research. In addition, Medicilon offers attractive large animal models (non-human primates, dogs, rabbits, and miniature pigs), tumor & non-tumor animal models (including Xenograft models, PDX / PDXO models), and support for simultaneous U.S. IND filing to streamline global drug development and approval.

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ITR Laboratories Canada Inc

Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 30 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with over 400 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. ITR is committed to providing the highest quality services to suit the needs of sponsors; our expert staff will continue to stay up-to-date with the latest technological developments to ensure we are always ready for new and challenging projects. | Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. We also offer juvenile toxicology services. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 30 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with nearly 500 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. ITR is committed to providing the highest quality services to suit the needs of sponsors; our expert staff will continue to stay up-to-date with the latest technological developments to ensure we are always ready for new and challenging projects. | Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. We also offer juvenile toxicology services. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 35 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with over 500 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. Our most recent expansion was completed in February of 2023 and added an additional 8 animal rooms for a total of 80 rooms. Specializing in inhalation toxicology, ITR has 22 exposure rooms with over 750 completed inhalation studies, ITR is ranked as the #1 inhalation CRO in the world. ITR is committed to providing the highest quality services tailored to the needs of sponsors; our expert staff continues to stay up-to-date with the latest technological developments to ensure readiness for new and challenging projects.

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iProcess Global Research Inc

iProcess Global Research Inc. is a leading global provider of biospecimens and laboratory services, with over 20 years of experience and a global network of over 1500 sites. | iProcess Global Research Inc. is a leading global provider of high-quality human biospecimens and comprehensive laboratory services, dedicated to empowering scientific research and accelerating medical breakthroughs. With more than 22 years of experience supporting the life sciences, pharmaceutical, biotechnology, and diagnostic industries, iProcess connects researchers to ethically sourced, clinically annotated human biospecimens through a robust network of 1,500+ pre-qualified clinical sites across over 30+ countries. Built on a foundation of strict regulatory compliance and quality excellence—including ISO 20387 and CAP/CLIA-aligned workflows—iProcess offers end-to-end solutions ranging from customized specimen collection and validated cold-chain logistics to advanced, AI-enhanced laboratory analysis and project management support. iProcess’s global biorepository and laboratory ecosystem provides seamless access to a broad range of human sample types and disease cohorts, enabling organizations to navigate complex research requirements with reliability, flexibility, and scientific integrity. Whether supporting clinical trial biospecimen procurement or delivering integrated lab services, iProcess is committed to advancing research and delivering data researchers can trust. As part of its continued expansion in laboratory services, iProcess is launching AxisOne.ai in February 2026—an AI-powered global R&D platform designed to connect organizations with world-class laboratories and research capabilities worldwide. AxisOne leverages artificial intelligence and deep analytics to accelerate feasibility, optimize lab selection, and streamline execution for specialized testing needs by bringing hundreds of labs and research sites onto a single intelligent platform.

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Insuvia

Insuvia is a trusted partner for biotech companies seeking regulatory compliance and pharmacovigilance support across clinical development and post-marketing stages. We specialize in helping biotechs navigate complex regulatory landscapes and manage drug safety, whether advancing through clinical trials, preparing for product launches, or expanding globally. | Insuvia is a trusted partner for biotech companies seeking regulatory compliance and pharmacovigilance support across clinical development and post-marketing stages. We specialize in helping biotechs navigate complex regulatory landscapes and manage drug safety, whether advancing through clinical trials, preparing for product launches, or expanding globally. Our tailored operating model is designed to meet the unique needs of biotech companies – offering agility, scalability, and personalized service. As a mid-sized provider, Insuvia combines the capacity to handle complex projects with the focused attention biotechs deserve. Backed by a highly experienced team, we enable our clients to achieve regulatory success and ensure patient safety.

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HitGen

HitGen Inc. (SSE: 688222.SH), founded in 2012, is headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen is committed to building a world-class innovative biopharmaceutical enterprise and contributing to the better life and health of mankind. Engaged in the discovery and optimization of small molecules and nucleic acid drugs, HitGen dedicates itself to cultivating an internationally leading drug discovery and optimization system centered on four key technology platforms, including DNA-encoded library technology (including DEL design, synthesis and screening, and application expansion), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). It provides new molecular entities (NMEs) at different stages of research and development for the pharmaceutical industry, through its diversified business models including research and development services, out-licensing of projects at different R&D stages, and new drug launches in the long term, with an aim to address unmet clinical needs with innovative therapeutic solutions. As a leader in the field of DEL technology, HitGen has been committed to the development, application and improvement of DEL technology since its establishment. By June 30, 2022, HitGen’s DELs contains more than 1.2 trillion novel, diverse, drug-like small molecules and macrocyclic compounds. These compounds are members of DELs synthesized from many thousands of distinct chemical scaffolds, designed with tractable chemistry, and have yielded proven results for the discovery of small molecule leads against precedented and unprecedented classes of biological targets. Through systematic DEL compound design, HitGen DELs has involved the use of more than 6000 different types of chemical scaffolds, which includes most of the core scaffolds of currently approved small-molecule drugs and many privileged scaffolds of small-molecules in clinical trials, and the approximately 40,000 different building blocks. HitGen has approximately 20 in-house drug discovery projects at different stages of research and development, among which 4 have obtained IND approvals and entered into clinical trials. HitGen is in collaboration with pharmaceutical, biotech and chemical companies, foundations and research institutes in the Americas, Asia, Europe, Africa, and Oceania. For more information, please call +86-28-85197385, +1-508-840-9646 or visit www.hitgen.com. For business development: bd@hitgen.com | HitGen Inc. (SSE: 688222.SH), is a drug discovery research company with headquarters in Chengdu, China, and subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). Through our diverse and flexible business models, we have built up collaboration partnership with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage. | About HitGen Inc. HitGen Inc. (SSE: 688222.SH), is a drug discovery research company headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid-based drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for oligonucleotide-based therapeutics (OBT), and targeted protein degradation technology (TPD). Meanwhile, we are developing a DEL+AI+ Automated DMTA (Design-Make-Test-Analyze) molecular optimization platform to accelerate the discovery and optimization process of preclinical candidate compounds. Through our diverse and flexible business models, we have built up collaboration partnerships with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage.

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HiComp

Established in 2014, HiComp Microtech stands as a premier original design manufacturer specializing in advanced microfluidics products and laboratory consumables. Our solutions boost precision, efficiency, and reliability from prototyping to mass production. Quality, performance and affordability are our priorities. | Established in 2014, HiComp Microtech is a leading original design manufacturer (ODM) specializing in advanced microfluidic products and laboratory consumables. Our ISO-certified and FDA-registered facilities span 100,000 sq. ft., including approximately 40,000 sq. ft. of high-standard cleanroom space. We provide precision, efficiency, and reliability from prototyping through volume production, serving renowned pharmaceutical and clinical diagnostic companies globally. With a proven track record, HiComp has successfully completed over 100 commercialized projects. Our services include: • Product Design • 3D Printing • CNC Micro Milling • MEMS Manufacturing • PDMS Manufacturing • Organoids/Organ on a Chip • Cleanroom Injection Molding • Surface Functionalization • Bonding & Sealing • Custom Microwell Plates • Assembly & Automation • Reagent Storage and Lyophilization

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