NABI Bio
North American Biomedical Institute
NABI Bio is a leading institute in India specializing in agri-food and biomanufacturing. They offer expertise in biocompatibility testing for various applications.
The National Agri-Food and Biomanufacturing Institute (NABI Bio) is a prominent research institution in India dedicated to advancements in agri-food and biomanufacturing. As a key player in the field, NABI Bio provides specialized services in biocompatibility testing, crucial for ensuring the safety and efficacy of various products and materials. Their commitment to innovation and research makes them a valuable partner for organizations seeking expert testing solutions in the biomanufacturing sector. NABI Bio's focus extends to cutting-edge research and development, fostering a collaborative environment for scientists and researchers. The institute's infrastructure supports a wide range of scientific disciplines, contributing to its robust capabilities in specialized testing services like biocompatibility. Their work is essential for industries that require stringent quality control and regulatory compliance.
About
**Who they are**
NABI Bio is an institute in India specializing in agri-food and biomanufacturing, offering expertise in biocompatibility testing for medical devices.
**Expertise & scope**
* Conducts biocompatibility assessments as part of the overall device safety evaluation, adhering to ISO 10993 standards.
* Provides comprehensive pre-clinical testing and consulting services for medical devices.
* Offers a broad field of tests, including Chemical Characterization, Toxicological evaluation, and various Cytotoxicity tests.
* Specializes in Biological Evaluation Plans (BEP) to determine potential risks and establish biological testing strategies in compliance with normative requirements.
* Performs specific cytotoxicity tests such as MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
**Reputation / proof points**
* Operates modern laboratories.
* Advises clients on cost-effective solutions.
NABI Bio is an institute in India specializing in agri-food and biomanufacturing, offering expertise in biocompatibility testing for medical devices.
**Expertise & scope**
* Conducts biocompatibility assessments as part of the overall device safety evaluation, adhering to ISO 10993 standards.
* Provides comprehensive pre-clinical testing and consulting services for medical devices.
* Offers a broad field of tests, including Chemical Characterization, Toxicological evaluation, and various Cytotoxicity tests.
* Specializes in Biological Evaluation Plans (BEP) to determine potential risks and establish biological testing strategies in compliance with normative requirements.
* Performs specific cytotoxicity tests such as MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
**Reputation / proof points**
* Operates modern laboratories.
* Advises clients on cost-effective solutions.
Additional information
NABI Bio's approach to biocompatibility testing involves a risk-based strategy, beginning with a Biological Evaluation Plan (BEP). This plan, crucial for medical devices with direct or indirect contact, leverages sponsor-provided data on materials, packaging, and production to identify potential risks and define the necessary testing. The institute emphasizes providing good and cost-effective solutions, utilizing their modern laboratory facilities to conduct a wide array of tests. Their services are designed to ensure compliance with relevant ISO 10993 standards, guiding clients through the complex process of biological evaluation as a key component of risk management.
Key Highlights
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Specializes in biocompatibility testing for medical devices according to ISO 10993 standards.
Source
“The biocompatibility assessment is part of the overall device safety assessment. Biocompatibility of medical devices has to be evaluated in the view of the latest ISO 10993 “Biological evaluation of medical devices”
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Offers comprehensive pre-clinical testing and consulting services.
Source
“We offer comprehensive pre-clinical testing and consulting services of medical devices.”
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Conducts a broad range of biocompatibility tests including Chemical Characterization, Toxicological evaluation, and various Cytotoxicity tests.
Source
“Below you find a list of biocompatibility tests, that we conduct routinely. Chemical Characterization Toxicological evaluation Cytotoxicity”
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Provides expertise in developing Biological Evaluation Plans (BEP) to ensure compliance with normative requirements.
Source
“A Biological Evaluation Plan is used to prove the safety of the device by demonstrating compliance to corresponding standards and avoiding unnecessary testing of the device.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 biocompatibility testing.
- Companies seeking pre-clinical testing and consulting services.
- Organizations needing assistance with Biological Evaluation Plans (BEP).
How engagement typically works
- Consultative approach to identify cost-effective solutions.
- Comprehensive testing and evaluation services.
- Guidance on regulatory compliance for medical devices.
Typical deliverables
- Biocompatibility test reports.
- Biological Evaluation Plans (BEP).
- Toxicological evaluations.
- Cytotoxicity test results.
Good to know
- Best when requiring specialized biocompatibility testing in India.
- Suitable for devices needing adherence to ISO 10993 standards.
HQ:
India
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Japan, Europe
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Biodegradation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
NABI Bio offers a comprehensive suite of biocompatibility testing services, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and biodegradation testing. They also provide in-house toxicology expertise.
Sample Requirements:
NABI Bio requires samples for biocompatibility testing. Specific requirements may vary based on the test being performed.
Rush Available:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 4-8 weeks
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$10-25k
Quote SLA:
3-5 business days
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5
Test Types Offered
Biocompatibility Testing, Chemical Characterization, Toxicological evaluation, Cytotoxicity (MEM Elution, Direct Contact, Agar Diffusion, MTT, XTT, Neutral Red Uptake)
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Pricing Model
Per project
