Inotiv
★★★★★
1.2
/ 5
•
17 reviews
Inotiv is a leading CRO offering comprehensive discovery, development, and research services. They specialize in toxicology, pathology, and providing a broad range of research models to support pharmaceutical and biotech companies.
Inotiv is a trusted partner for pharmaceutical and biotech companies, government, academia, and other life science organizations, providing a broad array of nonclinical and analytical services from discovery through clinical development. They offer comprehensive integrated solutions or standalone services for toxicology, including general toxicology studies under internationally recognized regulatory guidelines. Their expertise spans various models such as rodent, non-rodent, NHP, canine, swine, and rabbit, supported by computational toxicology for data analysis. Inotiv's pathology services deliver accurate interpretation and reporting for a broad spectrum of studies, tissues, species, and disease states, ensuring informed decisions with scientific insights. They also provide specialized research models, diets, and support services, including Teklad enrichment bedding products, to meet diverse toxicology research needs. With a focus on high-quality data and painstaking interpretation, Inotiv guides clients through regulatory pitfalls and equips them with strategic insights for success. Their commitment extends to maximizing animal well-being and research quality through enrichment solutions and providing reliable data for early de-risking of decisions. Inotiv's experienced scientific teams contribute to successful IND, NDA, and BLA submissions, offering timely and reliable data that meet regulatory requirements, including eCTD and SEND compliance.
About
**Who they are**
Inotiv is a Contract Research Organization (CRO) offering comprehensive discovery, development, and research services, specializing in toxicology and pathology to support pharmaceutical and biotech companies.
**Expertise & scope**
* Offers comprehensive integrated solutions or standalone services for general toxicology studies under internationally recognized regulatory guidelines.
* Supports safety evaluation for small molecule, biotherapeutic drug candidates, medical devices, or non-pharma products.
* Experienced scientific teams contribute to successful Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions.
* Provides timely and reliable data meeting regulatory requirements, including eCTD compliant reports and SEND compliant datasets.
* Utilizes a diverse range of rodent, non-rodent, NHP, canine, swine, and rabbit models.
* Offers computational toxicology expertise, drawing on assay data, in-house resources, and literature.
* Provides pathology services including routine semi-quantitative evaluations and fully quantitative assessment and reporting.
* Pathology services cover a broad spectrum of studies, tissues, species, and disease states, including Cardiovascular, Gastrointestinal, Hepatic, Infectious Disease, Inflammation and Immunology, Metabolic and Diabetic Disease, Neuroscience, Oncology, and Renal.
* Supports research phases from Discovery through IND-Enabling to Pre-Marketing Authorization.
**Reputation / proof points**
* Possesses a long and impeccable regulatory history.
* Offers a world-class team of scientists.
Inotiv is a Contract Research Organization (CRO) offering comprehensive discovery, development, and research services, specializing in toxicology and pathology to support pharmaceutical and biotech companies.
**Expertise & scope**
* Offers comprehensive integrated solutions or standalone services for general toxicology studies under internationally recognized regulatory guidelines.
* Supports safety evaluation for small molecule, biotherapeutic drug candidates, medical devices, or non-pharma products.
* Experienced scientific teams contribute to successful Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions.
* Provides timely and reliable data meeting regulatory requirements, including eCTD compliant reports and SEND compliant datasets.
* Utilizes a diverse range of rodent, non-rodent, NHP, canine, swine, and rabbit models.
* Offers computational toxicology expertise, drawing on assay data, in-house resources, and literature.
* Provides pathology services including routine semi-quantitative evaluations and fully quantitative assessment and reporting.
* Pathology services cover a broad spectrum of studies, tissues, species, and disease states, including Cardiovascular, Gastrointestinal, Hepatic, Infectious Disease, Inflammation and Immunology, Metabolic and Diabetic Disease, Neuroscience, Oncology, and Renal.
* Supports research phases from Discovery through IND-Enabling to Pre-Marketing Authorization.
**Reputation / proof points**
* Possesses a long and impeccable regulatory history.
* Offers a world-class team of scientists.
Additional information
Inotiv provides comprehensive toxicology and pathology services designed to support clients through various stages of product development, from discovery to regulatory submissions. They emphasize delivering high-quality data and expert interpretation to facilitate informed decision-making. Clients can engage Inotiv for integrated solutions or specific standalone services, tailored to their program's needs. The company highlights its ability to navigate regulatory pathways and provide strategic insights. Their pathology services are structured to manage projects efficiently from initiation through closeout, ensuring clear communication and timely deliverables. For toxicology, they offer flexible, targeted solutions utilizing a variety of research models and computational expertise.
Key Highlights
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Offers comprehensive toxicology studies under internationally recognized regulatory guidelines.
Source
“Inotiv provides general toxicology studies under internationally recognized regulatory guidelines for the safety evaluation of your small molecule, biotherapeutic drug candidate, medical device, or non-pharma product.”
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Experienced scientific teams contribute to successful IND, NDA, and BLA submissions.
Source
“Our experienced and proven scientific teams regularly contribute to successful Investigational New Drug application (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions.”
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Provides timely and reliable data meeting regulatory requirements, including eCTD and SEND compliance.
Source
“At Inotiv, you receive timely and reliable data that meet regulatory requirements and guidelines, including eCTD compliant reports and SEND compliant datasets.”
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Pathology services include expert interpretation for a broad spectrum of studies, tissues, species, and disease states.
Source
“Our experienced staff engage in consulting and expert interpretation for a broad spectrum of studies, tissues, species, and disease states.”
Certifications & Trust Signals
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Possesses a long and impeccable regulatory history.
Source
“Take advantage of our comprehensive services offering, long and impeccable regulatory history, world-class team of scientists, and track record of providing attentive, decisive support.”
Buyer Snapshot
Best for
- Companies needing comprehensive toxicology and pathology services.
- Support for regulatory submissions (IND, NDA, BLA).
How engagement typically works
- Integrated solutions or standalone services.
- Consultative approach with scientific teams.
Typical deliverables
- Toxicology study reports (eCTD compliant).
- SEND compliant datasets.
- Pathology interpretation and reporting.
- Scientific insights and strategic recommendations.
Good to know
- Best when requiring support for small molecule, biotherapeutic drug candidates, medical devices, or non-pharma products.
HQ:
US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Carcinogenicity, Reproductive toxicity, Biodegradation, Pharmacokinetics
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Inotiv provides general toxicology studies under internationally recognized regulatory guidelines for the safety evaluation of small molecule, biotherapeutic drug candidate, medical device, or non-pharma product. Our experienced and proven scientific teams regularly contribute to successful Investigational New Drug application (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions. We offer a broad array of nonclinical and analytical services from discovery through clinical development. Our computational toxicology group offers expertise across informatics areas, drawing on data from assays, in-house resources, and literature. Our pathologists have the capability and expertise to interpret studies accurately, offering consulting and expert interpretation for a broad spectrum of studies, tissues, species, and disease states.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Nda Support:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Additional biocompatibility_testing Details
Test Types Offered
General toxicology studies, Pathology evaluations, Computational toxicology
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
