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.
**Expertise & scope**
* Provides preclinical toxicology testing services under GLP and non-GLP conditions for safety assessment of pharmaceuticals, vaccines, medical devices, chemicals, natural health products, and pesticides.
* Conducts in vivo and in vitro studies to evaluate potential toxicity and safety, supporting regulatory submissions to agencies like the FDA and Health Canada for Investigational New Drug (IND) applications.
* Offers support for Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations, and REACH testing.
* Performs safety pharmacology studies, including core battery tests for the Central Nervous System, cardiovascular, and respiratory systems, as outlined by ICH S7A.
* Conducts USP <151> Pyrogen Tests for pharmaceutical products intended for parenteral administration.
* Performs OECD 402 Acute Dermal Toxicity tests using the Fixed Dose Procedure on rats.
* Conducts OECD 404 Acute Dermal Irritation/Corrosion tests on rabbits.
* Performs OECD 405 Acute Eye Irritation/Corrosion tests on rabbits.
* Conducts 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.
**Expertise & scope**
* Provides preclinical toxicology testing services under GLP and non-GLP conditions for safety assessment of pharmaceuticals, vaccines, medical devices, chemicals, natural health products, and pesticides.
* Conducts in vivo and in vitro studies to evaluate potential toxicity and safety, supporting regulatory submissions to agencies like the FDA and Health Canada for Investigational New Drug (IND) applications.
* Offers support for Biocompatibility (ISO 10993), Generally Recognized as Safe (GRAS) determinations, and REACH testing.
* Performs safety pharmacology studies, including core battery tests for the Central Nervous System, cardiovascular, and respiratory systems, as outlined by ICH S7A.
* Conducts USP <151> Pyrogen Tests for pharmaceutical products intended for parenteral administration.
* Performs OECD 402 Acute Dermal Toxicity tests using the Fixed Dose Procedure on rats.
* Conducts OECD 404 Acute Dermal Irritation/Corrosion tests on rabbits.
* Performs OECD 405 Acute Eye Irritation/Corrosion tests on rabbits.
* Conducts 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 supports clients with a range of toxicology testing programs, from routine to novel. Their preclinical toxicology lab utilizes a variety of rodent and non-rodent animal models for in vivo studies, with several routes of administration routinely employed. They emphasize the critical role of well-designed and executed studies for regulatory submissions globally. For specific tests like the USP Pyrogen Test, they typically use a minimum of 3 rabbits and record temperatures for 3 hours post-injection. For dermal and eye irritation/corrosion tests, they follow OECD guidelines and typically require 10 grams of test article.
Key Highlights
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Over 50 years of experience in contract support for regulated 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 GLP and non-GLP preclinical toxicology testing.
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.
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”
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Performs USP <151> Pyrogen Tests for injectable products.
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 many 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 like 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 testing services.
- Support for IND-enabling studies.
- Consultation on study design and regulatory requirements.
Typical deliverables
- GLP toxicology study reports.
- Safety pharmacology study reports.
- Pyrogen test reports.
- Acute toxicity study reports (dermal, eye).
- Skin sensitization study reports.
Good to know
- Best when requiring established, GLP-compliant testing methodologies.
- Suitable for products requiring evaluation for pharmaceutical, medical device, or chemical safety.
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, FDA, Standards Council of Canada
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
Rush Available:
No
Sample Requirements:
Typically 10 grams of test article required for OECD 402.
Nda Support:
No
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Preclinical Toxicology Testing, Safety Pharmacology Studies, Pyrogen Testing (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
