Preclinical Toxicology Lab Services Overview
Nucro-Technics provides in vivo and in vitro nonclinical / preclinical toxicology testing lab services under both GLP and non-GLP conditions for the safety assessment of pharmaceuticals products, vaccines, medical devices, chemicals, natural health products / botanicals, and pesticides. Studies performed by Nucro-Technics’ preclinical toxicology lab are designed to evaluate the potential toxicity and safety of test substances across a range of parameters. 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 and enable progression into clinical trials.
With over 50 years of experience, Nucro-Technics supports clients from early-stage research through to regulatory approval. 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. Our knowledge and decades of expertise allow us to support both routine and more novel toxicology testing programs.
What Types of Studies are Performed
The types of services offered at Nucro-Technics’ preclinical toxicology lab are very broad but can broadly be categorized in a number of different ways.
What Models and Routes of Administration are Offered?
Nucro-Technics’ preclinical toxicology laboratory offers a wide array of rodent and non-rodent animal models that are typical for an IND-development program. The following routes of administration are routinely used for both GLP and non-GLP in vivo studies conducted at Nucro-Technics:
- Oral
- Intravenous (bolus and infusion)
- Dermal
- Subcutaneous
- Implant
- Intramuscular
- Intraperitoneal
- Ocular
- Intradermal
- Nasal Instillation
Why Conduct your Preclinical Toxicology Program at Nucro-Technics?
Well-designed and well-executed preclinical toxicology studies performed by a competent lab are critical to the success of any drug development program. These studies provide the data necessary to evaluate the safety of new compounds and support regulatory submissions globally.
Nucro-Technics operates under OECD GLP guidelines, and the high-quality safety data generated enables global submission to agencies such as Health Canada, the US FDA, TGA, EMA, and other international regulatory bodies. Nucro-Technics is fully accredited to perform both GLP preclinical and GMP release testing. Our integrated facility houses in-house capabilities in bioanalysis, genetic toxicology, preclinical toxicology, analytical chemistry, and microbiology.
We take a consultative approach, working closely with our clients to deliver high-quality, responsive service that aligns with regulatory expectations and project timelines.