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 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 either the Guinea Pig Maximization Test (GPMT) or the Buehler Test Method.
**Reputation / proof points**
* Over 50 years of experience.
* Supports regulatory submissions to agencies such as the FDA and Health Canada.
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 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 either the Guinea Pig Maximization Test (GPMT) or the Buehler Test Method.
**Reputation / proof points**
* Over 50 years of experience.
* Supports regulatory submissions to agencies such as the FDA and Health Canada.
Additional information
Nucro Technics offers a range of toxicology studies critical for regulatory submissions and product safety assessments. Their services include acute toxicity testing (dermal, eye, skin sensitization), pyrogen testing, and safety pharmacology studies. They work with various animal models, including rodents and non-rodents, and adhere to Good Laboratory Practice (GLP) regulations for many of their studies. The company supports clients from early research phases through to regulatory approval, providing data necessary for Investigational New Drug (IND) applications and other regulatory pathways.
Key Highlights
-
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.”
-
Supports Investigational New Drug (IND) applications, Biocompatibility (ISO 10993), GRAS determinations, and REACH 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.”
-
Performs a range of OECD test guidelines including OECD 402 (Acute Dermal Toxicity), OECD 404 (Acute Dermal Irritation/Corrosion), OECD 405 (Acute Eye Irritation/Corrosion), and OECD 406 (Skin Sensitization).
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), in order to support classification and labeling.”
-
Conducts USP <151> Pyrogen Testing for injectable pharmaceutical products.
Source
“The rabbit pyrogen test, per USP <151>, is a method used to detect the presence of pyrogens.”
Certifications & Trust Signals
-
Operates under Good Laboratory Practice (GLP) regulations for many of its toxicology studies.
Source
“Nucro-Technics provides in vivo and in vitro nonclinical / preclinical toxicology testing lab services under both GLP and non-GLP conditions”
-
Supports regulatory submissions to agencies including 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
- Medical device manufacturers requiring ISO 10993 testing.
- Pharmaceutical and biotech companies needing IND-enabling toxicology studies.
- Chemical companies requiring regulatory safety assessments.
How engagement typically works
- Project-based testing.
- Support for regulatory submissions.
Typical deliverables
- GLP toxicology study reports.
- Safety pharmacology study reports.
- Pyrogen test results.
- Acute toxicity test results (dermal, eye, skin sensitization).
Good to know
- Best when specific OECD or USP test guidelines are required.
- Best when GLP compliance is a necessity for regulatory submissions.
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 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
