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 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 a wide array of safety pharmacology studies, including CNS, cardiovascular, and respiratory system assessments, 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 either 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 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 a wide array of safety pharmacology studies, including CNS, cardiovascular, and respiratory system assessments, 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 either 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 provides a comprehensive suite of toxicology and safety testing services essential for regulatory submissions. Their expertise spans various OECD guidelines and pharmacopeial standards, including USP and pharmacopeias from Europe and Japan. They are equipped to handle studies requiring GLP compliance, which is critical for IND-enabling programs. The company supports a broad range of product types, from pharmaceuticals and vaccines to medical devices and chemicals. Engagement typically involves detailed study design, execution under controlled conditions, and delivery of data suitable for regulatory review.
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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Offers comprehensive preclinical toxicology testing under both GLP and non-GLP conditions.
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 Biocompatibility (ISO 10993) testing as part of IND-enabling programs.
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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Performs a range of acute toxicity studies including OECD 402 (Dermal), OECD 404 (Dermal Irritation/Corrosion), and OECD 405 (Eye Irritation/Corrosion).
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”
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Conducts OECD 406 Skin Sensitization tests using either the Guinea Pig Maximization Test or the Buehler Test Method.
Source
“OECD 406, also known as the Skin Sensitization test, is used to identify substances with the potential to cause allergic contact dermatitis or skin sensitization in humans.”
Certifications & Trust Signals
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Conducts studies in compliance with Good Laboratory Practice (GLP) regulations.
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 GLP-compliant preclinical toxicology studies.
- Medical device manufacturers needing ISO 10993 biocompatibility testing.
- Pharmaceutical and biotech firms advancing drug development programs.
How engagement typically works
- Project-based study execution.
- Collaborative study design and consultation.
- Support for regulatory submissions.
Typical deliverables
- GLP toxicology study reports.
- Safety pharmacology study reports.
- Pyrogen test results.
- OECD guideline study reports.
Good to know
- Best when specific OECD or USP guideline testing is required.
- Best when GLP compliance is a prerequisite for study data.
HQ:
Mississauga, CA
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
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
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
