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 focus on providing high-quality data and expert interpretation to answer critical questions at various stages of development.
**Expertise & scope**
* Expert interpretation of studies, tissues, species, and disease states, including routine semi-quantitative and fully quantitative assessments.
* Services span from discovery through nonclinical and clinical development, aiming to guide clients past regulatory pitfalls.
* Specializes in toxicology, offering general toxicology studies under international regulatory guidelines for small molecules, biotherapeutics, medical devices, and non-pharma products.
* Utilizes a range of research models including rodent, non-rodent, NHP, canine, swine, and rabbit.
* Offers computational toxicology expertise, drawing on assay data, in-house resources, and literature.
* Provides pathology services including consulting and expert interpretation for a broad spectrum of studies.
**Reputation / proof points**
* Experienced scientific teams contribute to successful Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions.
* Delivers timely and reliable data meeting regulatory requirements, including eCTD compliant reports and SEND compliant datasets.
* Offers comprehensive integrated solutions or standalone services for toxicology programs.
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 focus on providing high-quality data and expert interpretation to answer critical questions at various stages of development.
**Expertise & scope**
* Expert interpretation of studies, tissues, species, and disease states, including routine semi-quantitative and fully quantitative assessments.
* Services span from discovery through nonclinical and clinical development, aiming to guide clients past regulatory pitfalls.
* Specializes in toxicology, offering general toxicology studies under international regulatory guidelines for small molecules, biotherapeutics, medical devices, and non-pharma products.
* Utilizes a range of research models including rodent, non-rodent, NHP, canine, swine, and rabbit.
* Offers computational toxicology expertise, drawing on assay data, in-house resources, and literature.
* Provides pathology services including consulting and expert interpretation for a broad spectrum of studies.
**Reputation / proof points**
* Experienced scientific teams contribute to successful Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions.
* Delivers timely and reliable data meeting regulatory requirements, including eCTD compliant reports and SEND compliant datasets.
* Offers comprehensive integrated solutions or standalone services for toxicology programs.
Additional information
Inotiv's approach to pathology and toxicology studies emphasizes collaboration and clear communication from project initiation through closeout. They facilitate detailed discussions regarding project goals, expectations, study plans, potential outcomes, and capabilities to ensure alignment. The company provides a structured project onboarding and planning process, followed by execution and monitoring, culminating in project deliverables and closeout discussions to address open questions and issue final reports. This structured methodology aims to provide scientific insights and support informed decision-making throughout the research and development lifecycle.
Key Highlights
-
Inotiv provides 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.”
-
Their pathology team offers 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.”
-
Supports successful Investigational New Drug (IND), New Drug Application (NDA), and Biologic License Application (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.”
-
Offers both integrated solutions and standalone services for toxicology programs.
Source
“We can provide a full safety assessment solution including customized study designs, dependable study conduct, sample analysis and data interpretation and reporting—or you can take advantage of our standalone services.”
Certifications & Trust Signals
-
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 seeking comprehensive toxicology and pathology services.
- Organizations requiring expert interpretation of research data.
- Biotech and pharmaceutical firms navigating regulatory submissions.
How engagement typically works
- Consultative approach to project planning.
- Dedicated pathology and scientific teams.
- Collaborative communication throughout study lifecycle.
Typical deliverables
- Expert pathology reports.
- Toxicology study data and interpretation.
- eCTD compliant reports and SEND compliant datasets.
- Consulting on study design and outcomes.
Good to know
- Best when requiring specialized expertise in toxicology and pathology.
- Best when needing support for IND, NDA, and BLA submissions.
HQ:
US
Languages:
English
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, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Carcinogenicity, Reproductive toxicity, Biodegradation, Pharmacokinetics, Other
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 diverse capabilities enable us to offer flexible, targeted solutions to meet your needs at various phases of your program. We can provide a full safety assessment solution including customized study designs, dependable study conduct, sample analysis and data interpretation and reporting—or you can take advantage of our standalone services. Inotiv’s computational toxicology group offers a wide range of expertise across informatics areas, allowing us to draw on data from your assays, in-house resources, and relevant literature to deliver the insights you need. Our pathologists have the capability and expertise to interpret your study accurately. Our experienced staff engage in 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 (semi-quantitative, quantitative)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
