Nucro Technics
Nucro Technics Inc.
For more than 50 years, Nucro-Technics has been a leading Contract Support Organization for the pharmaceutical, biotech, medical device, and marijuana industries.
biocompatibility testing: For more than 50 years, Nucro-Technics has been a leading Contract Support Organization for the pharmaceutical, biotech, medical device, and marijuana industries.
Nucro-Technics conducts GMP & GLP-Compliant Chemistry, Microbiology, Toxicology, Genetic Toxicology, and Bioanalytical Testing to fulfill FDA, Health Canada, and European requirements.
▪ GMP Release Testing ▪ GLP IND-Enabling Studies ▪ Medical Device Testing ▪ Marijuana Testing & Profiling ▪ QA & Regulatory Affairs Consulting
About
**Who they are**
Nucro Technics is a Contract Support Organization with over 50 years of experience, serving the pharmaceutical, biotech, medical device, and marijuana industries. They specialize in preclinical toxicology testing services.
**Expertise & scope**
* Conducts in vivo and in vitro nonclinical/preclinical toxicology testing under GLP and non-GLP conditions.
* Evaluates potential toxicity and safety of test substances for regulatory review by agencies like the FDA and Health Canada.
* Supports Investigational New Drug (IND) applications, Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations, and REACH testing.
* Performs safety pharmacology studies, including core battery tests for CNS, cardiovascular, and respiratory systems, following ICH S7A guidelines.
* Offers USP <151> Pyrogen Testing for injectable products.
* Conducts OECD 402 Acute Dermal Toxicity tests (Fixed Dose Procedure) on rats.
* Performs OECD 404 Acute Dermal Irritation/Corrosion tests on rabbits.
* Conducts OECD 405 Acute Eye Irritation/Corrosion tests on rabbits.
* Performs OECD 406 Skin Sensitization tests using the Guinea Pig Maximization Test (GPMT) or the Buehler Test Method.
**Reputation / proof points**
* Over 50 years of experience.
* Supports clients from early-stage research through to regulatory approval.
Nucro Technics is a Contract Support Organization with over 50 years of experience, serving the pharmaceutical, biotech, medical device, and marijuana industries. They specialize in preclinical toxicology testing services.
**Expertise & scope**
* Conducts in vivo and in vitro nonclinical/preclinical toxicology testing under GLP and non-GLP conditions.
* Evaluates potential toxicity and safety of test substances for regulatory review by agencies like the FDA and Health Canada.
* Supports Investigational New Drug (IND) applications, Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations, and REACH testing.
* Performs safety pharmacology studies, including core battery tests for CNS, cardiovascular, and respiratory systems, following ICH S7A guidelines.
* Offers USP <151> Pyrogen Testing for injectable products.
* Conducts OECD 402 Acute Dermal Toxicity tests (Fixed Dose Procedure) on rats.
* Performs OECD 404 Acute Dermal Irritation/Corrosion tests on rabbits.
* Conducts OECD 405 Acute Eye Irritation/Corrosion tests on rabbits.
* Performs OECD 406 Skin Sensitization tests using the Guinea Pig Maximization Test (GPMT) or the Buehler Test Method.
**Reputation / proof points**
* Over 50 years of experience.
* Supports clients from early-stage research through to regulatory approval.
Additional information
Nucro Technics supports a broad range of toxicology testing programs, from routine to novel. They utilize various animal models, including rodent and non-rodent species, and offer multiple routes of administration for in vivo studies. Their services are designed to generate data critical for regulatory submissions and drug development programs. For specific tests like OECD 402, 404, and 405, they typically require 10 grams of test article and perform studies in accordance with Good Laboratory Practice regulations. The USP <151> Pyrogen Test is conducted using a minimum of 3 rabbits.
Key Highlights
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Over 50 years of experience in contract support for pharmaceutical, biotech, and medical device industries.
Source
“With over 50 years of experience, Nucro-Technics supports clients from early-stage research through to regulatory approval.”
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Expertise in IND-enabling toxicology studies, including safety pharmacology and biocompatibility testing (ISO 10993).
Source
“We are well positioned to support clients’ Investigational New Drug (IND) Application, Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) testing services.”
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Conducts a range of OECD guideline studies including Acute Dermal Toxicity (402), Dermal Irritation/Corrosion (404), Eye Irritation/Corrosion (405), and Skin Sensitization (406).
Source
“The OECD 402 Acute Dermal Toxicity test is used to assess the potential short-term hazards of a chemical substance when exposed through the skin (dermal exposure)”
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Performs USP <151> Pyrogen Testing for pharmaceutical products intended for parenteral administration.
Source
“The rabbit pyrogen test, per USP <151>, is a method used to detect the presence of pyrogens.”
Certifications & Trust Signals
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Operates under Good Laboratory Practice (GLP) regulations for preclinical studies.
Source
“Nucro-Technics provides in vivo and in vitro nonclinical / preclinical toxicology testing lab services under both GLP and non-GLP conditions”
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Supports regulatory submissions to agencies such as the FDA and Health Canada.
Source
“They are submitted for regulatory review to agencies like the FDA and Health Canada which would then support the approval of Investigation New Drug (IND) applications”
Buyer Snapshot
Best for
- Companies requiring preclinical toxicology testing for IND applications.
- Medical device manufacturers needing biocompatibility assessments.
- Pharmaceutical and biotech firms seeking safety pharmacology and pyrogen testing.
How engagement typically works
- Project-based testing services.
- Support for regulatory submissions (FDA, Health Canada, EMA).
Typical deliverables
- GLP toxicology study reports.
- Safety pharmacology study reports.
- Pyrogen test results.
- Acute toxicity and irritation/corrosion study reports.
- Skin sensitization study reports.
Good to know
- Best when GLP compliance is required.
- Suitable for products requiring evaluation for parenteral administration.
Pricing
Model:
Per project
HQ:
Mississauga, CA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-11
Test Types Offered:
Irritation, Systemic toxicity, Pyrogenicity, Other
Is Accredited:
Yes
Accreditation Body:
Health Canada, the FDA, the Standards Council of Canada, and ISO-certified to the 9001: 2015 standard
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Preclinical toxicology, bioanalysis, genetic toxicology, analytical chemistry, and microbiology.
Regions Served:
Canada, USA, Europe
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Minimum Project Size:
$25-50k
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Preclinical Toxicology Testing, Safety Pharmacology Studies, Pyrogen Test (USP <151>), Acute Dermal Toxicity (OECD 402), Acute Dermal Irritation/Corrosion (OECD 404), Acute Eye Irritation/Corrosion (OECD 405), Skin Sensitization (OECD 406)
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
$25-50k
Pricing Model
Per project
