VisMederi offers qualified services to the pharmaceutical industries operating in the field of vaccines, especially against influenza, but recently also against meningococcus and other emerging or re-emerging infectious diseases (Yellow Fever, Typhoid Fever, Dengue, Chikungunya, West Nile, Zika). For ten years, the company has played a leading role at international level in the development of serological tests necessary for the registration and marketing of influenza vaccines by regulatory bodies such as EMA (European Medicines Agency) and FDA (Food and Drug Administration). VisMederi possesses laboratories and research facilities necessary to completely cover all procedures required for the development of phase II, III, and IV of clinical trials and avails of the synergy it has with laboratories and research facilities and international research centers for the development of pre-clinical protocols and phase I studies.
All tests conducted by VisMederi are designed, validated and conducted according to international guidelines and periodically updated based on the requests of the sponsors. To meet the need to test the effectiveness of innovative products developed by our sponsors, the company has expanded its test panel available alongside traditional assays such as Haemagglutination Inhibition (HAI), Single Radial Hemolysis (SRH) and Virus Neutralization (VN), with new methods. Among these, there are microneutralization tests using pseudoviral particles, enzyme immunoassays for the evaluation of the response to neuraminidase (ELLA test), analysis of cell-mediated immune response through ELISpot and FACS platforms, and quantization of IgA levels by ELISA test performed in serum, saliva and nasal wash samples. VisMederi also carries out tests for the immune evaluation of bacterial vaccines, through the SBA test (Serum Bacericidial Assay), OPA (Opsonophagocytosis Assay) and MATS (Meningococcal Antigen Typing System).
Recently, in addition to the isolation of microorganisms in cell cultures and the molecular identification of viral and bacterial isolates from clinical samples, VisMederi has validated methods of quantization of microorganisms through real-time PCR.
To satisfy the growing demand to cover all stages of vaccine development, and not just to the clinical phases, VisMederi has developed a platform for preclinical studies using animal models such as ferrets, mice and recently also cotton rats.
VisMederi offers to the companies the opportunity to store biological material, such as serums collected during clinical studies, having three new temperature-controlled storage areas and a 24-hour monitoring system at disposal. The service is designed to be customized according to the needs of the partners including the ability to manage the shipment of the material.
Since 2013 the company has a new division specialized in consulting services (regulations relating to safety and health of the workplace, food traceability, compliance with environmental regulations) and chemical-physical and microbiological analyzes in the food, environment and agriculture sectors through investigations on any type of food, on work surfaces, on water and the environment.
VisMederi carries out all the activities in accordance with the European certification system UNI EN ISO 9001: 2015, in addition to having the following accreditations: UNI CEI EN ISO / IEC 17025: 2005 test laboratories, UNI EN ISO 15189: 2013 medical laboratories, Good Clinical Laboratory Practice (GCLP) ISBN 978-1-904610-00-7.
