Our services include from Non-GLP dose range finding studies to sub-chronic and chronic toxicology in rodent and non-rodent models. These capabilities for conducting all type of general toxicology studies, together with the wide range of services provided by Viviotecnia, enable us to offer you from stand-alone studies to “First Time In Human” or “Full Development” complete study packages.
Vivotecnia operates under rigorously enforced quality standards while remaining flexible. We can tailor our efforts to nearly any special procedures that are requested or designed to meet the specific demands of each client and trial. We strive to attract and retain our clients through exceptional expertise at competitive pricing, strong communication, timeliness, responsive and cost-effective preclinical research services.
- Acute/Single Dose
- Subacute (7,14 or 28 days)
- Subchronic (13 weeks)
- Chronic (6 months, 9 months, and over one year in duration)
- Guinea pigs
- Non-Human Primates
- Oral (Gavage, Capsule, Diet, Drinking water…)
- Parenteral (I.V., I.M., S.C., I.P., etc)
- Continuous infusion
- Vaginal, rectal
Formulation analysis and Bio-Analysis available to support all projects:
- Small molecules
- Natural Products
Equipment and Facilities
Hight quality animal facilities
Our newly renovated, state-of-the-art animal facilities cover over 2680 square feet of space including a 328 square feet dedicated non-human primate facility. Our multispecies facilities can be customized to meet the specific requirements of each individual study with strict adherence to the Animal Welfare regulations and standards as set by the animal protection competent authorities.
Our constant upgrading of our animal facilities and equipment has resulted in an energy-efficient and cost-competitive non-clinical research center. The facilities are provided with state-of-the-art HVAC system and the animal rooms are always supplied with 100% fresh air. The animal facility is continuously monitored for environmental parameters like room temperature, relative humidity and differential pressure, through an integrated building management system (BMS).
Clinical Pathology Services
Vivotecnia offers extensive GLP-compliant clinical pathology testing services to support general toxicity studies. Our fully equipped automated laboratory facilities provide consistent quality and rapid hematology, coagulation, clinical biochemistry and urinalysis standard determinations. We can provide you also with specialized laboratory services to meet your particular development needs for assays/biomarkers for other specific safety studies.
Anatomic Pathology Services
Our state-of-the-art necropsy and anatomic pathology labs and selected partners are staffed by some of the best trained technicians and most experienced, board certified toxicologic pathologist which can offer from routine procedures to highly specialized methods to support your non-clinical development program.
Our team and Experience
Vivotecnia has some of the most experienced, most talented minds in the industry, working closely with our clients while remaining flexible and responsive to find solutions to your needs. The extensive experience of our team of scientist represent a wide range of disciplines and all of them are fully committed to your non-clinical development program. Their extensive experience with complex general toxicology studies and their ability to respond to unexpected issues, enable you to achieve robust and regulatory compliant data, keeping you moving forward with your registration process.
- Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2).
- ICH Guideline S6 (R1): “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals”
- ICH Guideline S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
- ICH S4 Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing)
- EMEA/CHMP/SWP/488313/2007 Guideline on Repeated dose Toxicity Testing
- EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1 Guideline on non-clinical local tolerance testing of medicinal products
- EMEA/CHMP/GTWP/125459/2006 Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products
- WHO guidelines on nonclinical evaluation of vaccines. Annex I of WHO Technical Report Series, No. 927, 2005
- EMA/CHMP/BMWP/403543/2010 Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
- EMEA/CHMP/SWP/169215/2005 Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for pediatric indications
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Our in-house team of veterinarians ensure that animal welfare is paramount and are committed to the principals of the 3Rs (refinement, reduction, replacement)