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) that offers comprehensive discovery, development, and research services, specializing in toxicology and pathology to support pharmaceutical and biotech companies. They aim to provide high-quality data and interpretation to answer critical questions at the right time.
**Expertise & scope**
* Comprehensive discovery, development, and research services.
* Specialization in toxicology, pathology, and a broad range of research models.
* Services include routine semi-quantitative evaluations to fully quantitative assessment and reporting for pathology studies.
* Expert interpretation for a broad spectrum of studies, tissues, species, and disease states.
* Offers general toxicology studies under internationally recognized regulatory guidelines for small molecule, biotherapeutic drug candidates, medical devices, or non-pharma products.
* Supports Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions with timely and reliable data.
* Provides eCTD compliant reports and SEND compliant datasets.
* Utilizes rodent, non-rodent, NHP, canine, swine, and rabbit models for toxicology programs.
* Computational toxicology group offers expertise in informatics to draw on data from assays, in-house resources, and literature.
* Offers Teklad enrichment bedding products and Teklad Global Diets for toxicology studies.
**Reputation / proof points**
* Long and impeccable regulatory history.
* World-class team of scientists.
Inotiv is a Contract Research Organization (CRO) that offers comprehensive discovery, development, and research services, specializing in toxicology and pathology to support pharmaceutical and biotech companies. They aim to provide high-quality data and interpretation to answer critical questions at the right time.
**Expertise & scope**
* Comprehensive discovery, development, and research services.
* Specialization in toxicology, pathology, and a broad range of research models.
* Services include routine semi-quantitative evaluations to fully quantitative assessment and reporting for pathology studies.
* Expert interpretation for a broad spectrum of studies, tissues, species, and disease states.
* Offers general toxicology studies under internationally recognized regulatory guidelines for small molecule, biotherapeutic drug candidates, medical devices, or non-pharma products.
* Supports Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions with timely and reliable data.
* Provides eCTD compliant reports and SEND compliant datasets.
* Utilizes rodent, non-rodent, NHP, canine, swine, and rabbit models for toxicology programs.
* Computational toxicology group offers expertise in informatics to draw on data from assays, in-house resources, and literature.
* Offers Teklad enrichment bedding products and Teklad Global Diets for toxicology studies.
**Reputation / proof points**
* Long and impeccable regulatory history.
* World-class team of scientists.
Additional information
Inotiv emphasizes a structured project approach, from initial consultation and planning through execution, monitoring, and final reporting. They focus on understanding client goals and timelines to deliver scientific insights and informed decisions. Their services span various research phases, including Discovery, IND-Enabling, and Pre-Marketing Authorization. For toxicology, they offer integrated solutions or standalone services, adaptable to different program phases. Buyers can expect attentive and decisive support throughout their projects.
Key Highlights
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Offers comprehensive discovery, development, and research services.
Source
“As your discovery and development partner, Inotiv delivers both—along with a broad array of models, services and expertise to exceed your expectations.”
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Specializes in toxicology and pathology with expertise across various species and disease states.
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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Supports regulatory submissions including IND, NDA, and BLA.
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 eCTD compliant reports and SEND compliant datasets.
Source
“At Inotiv, you receive timely and reliable data that meet regulatory requirements and guidelines, including eCTD compliant reports and SEND compliant datasets.”
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.”
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Employs a world-class team of scientists.
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 seeking comprehensive toxicology and pathology services.
- Pharmaceutical and biotech firms needing support from discovery through regulatory submissions.
How engagement typically works
- Consultative approach to define project scope and goals.
- Attentive and decisive support throughout the project lifecycle.
Typical deliverables
- Pathology study reports (semi-quantitative to quantitative).
- Toxicology study reports compliant with regulatory guidelines.
- eCTD compliant reports and SEND compliant datasets.
- Scientific insights and data interpretation.
Good to know
- Best when requiring specialized CRO services for drug development and medical device safety evaluation.
HQ:
US
Languages:
English
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
Additional biocompatibility_testing Details
Test Types Offered
General toxicology studies, Pathology evaluations (semi-quantitative, quantitative)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Custom
