general toxicology

General Toxicology

At Vivotecnia we help our clients to conduct preclinical, GLP-compliant, general toxicology studies to evaluate the safety of new drug candidates. This process adheres to international regulatory requirements and submission requirements for clinical trials or marketing authorization.

Our general toxicology services comprise anything from non-GLP dose-range-finding studies to subchronic and chronic toxicology studies in rodent and nonrodent models. This along with Vivotecnia’s comprehensive service catalog means that we can offer you anything from stand-alone studies to complete first-in-human or full development study packages.

Vivotecnia operates under rigorously enforced quality standards, adapting our efforts to nearly any special procedure that is 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 prices, with fluid communication, on-time delivery, and fast and cost-effective preclinical research services.

  • Acute/single dose
  • Subacute (7,14 or 28 days)
  • Subchronic (13 weeks)
  • Chronic (six-month, nine-month, and over one-year duration)
  • Oral (gavage, capsule, diet, drinking water, etc.)
  • Parenteral (iv, im, sc, ip, etc.)
  • Continuous infusion
  • Dermal
  • Ocular
  • Vaginal, rectal
  • Inhalation
Formulation analysis and bioanalysis are available to support all projects:

  • Small molecules
  • Biologics
  • Natural products
  • Vaccine
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Equipment and Facilities
High-quality animal facilities

Our newly renovated, state-of-the-art animal facilities cover over 2680 sq. ft. with 328 sq. ft. dedicated to our nonhuman primate facility. This multispecies facility is customizable to adapt to the specific requirements of each study with strict adherence to animal welfare regulations and standards as set by the relevant animal protection authorities.

Our constant upgrading of our animal facilities and equipment has resulted in an energy-efficient and cost-competitive nonclinical research center. The facilities are equipped with a state-of-the-art HVAC system and animal rooms are continuously supplied with 100% fresh air. An integrated building management system (BMS) constantly monitors environmental parameters like room temperature, relative humidity and differential pressure in the animal facility.

Clinical Pathology Services

Vivotecnia offers comprehensive GLP-compliant clinical pathology testing services to support general toxicology studies. Our fully equipped, automated laboratory facilities provide consistent quality and rapid standard hematology, coagulation, clinical biochemistry and urinalysis determinations. We can provide you with specialized laboratory services to meet your particular development needs for assays or 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 pathologists who can offer anything from routine procedures to highly specialized methods to support your nonclinical development program.

Our team and experience

Vivotecnia employs some of the most experienced and talented minds in the industry who work closely with our clients, always flexible and responsive to find solutions and satisfy your needs. Our scientific team has extensive experience and widely varied backgrounds in multiple disciplines and is fully committed to your nonclinical development program. Their years of experience with complex general toxicology studies and their ability to respond to unexpected issues mean that you will obtain robust and regulatory compliant data, keeping you on-track and progressing with your registration process.

Methodology
 

 

  • Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010
  • Guideline on non-clinical local tolerance testing of medicinal products, EMA/CHMP/SWP/2145/2000 Rev. 1, Corr. 1
  • Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products, EMEA/CHMP/GTWP/125459/2006
  • Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for pediatric indications, EMEA/CHMP/SWP/169215/2005
  • Guideline on repeated dose toxicity, EMEA/CHMP/SWP/488313/2007
  • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ICH M3(R2), June 2009
  • Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing), ICH S4, September 1998
  • Preclinical safety evaluation of biotechnology-derived pharmaceuticals, ICH S6(R1), June 2011
  • Nonclinical evaluation for anticancer pharmaceuticals, ICH S9, October 2009
  • WHO guidelines on nonclinical evaluation of vaccines, Annex 1 of WHO Technical Report Series, No. 927, 2005

CONTACT

For more information or a formal quotation, please send us a message and we will contact you as soon as possible.



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