Regulatory Compliance Consulting

Sovicille (SI), Italy

HISTORY The company's history began in 1904 when Achille Sclavo discovered anti-anthrax serum and he founded the Tuscan Serotherapy and Vaccinogen Institute in Siena. During the First World War, the Institute extended the production of serums and bacterial vaccines to an industrial level. In 1929 the Institute began the production of anti-diphtheria and anti-tetanus anatoxin and, later, of the smallpox vaccine. In 1934 the first diagnostic product appeared as a medical adjuvant for a correct medical diagnosis. These products began to be patented and approved by the Food and Drug Administration in 1977. Today the company is specialized in the production of high range diagnostic reagents using high-quality raw materials with standardized and certified internal processes PRODUCTION SITE The company is located in Sovicille (Siena). There are various departments dedicated to: ▪ Production (Bacteriology, Serology, Clinical Chemistry-Specific Proteins) ▪ Research and Development ▪ Quality Control ▪ Design and development of analyzers. There is also a safety area for the manufacturing of flammable substances. PRODUCTS Sclavo Diagnostics boasts a high value know-how in the microbiological sector, with the production of diagnostic reagents in the bacteriological, serological, clinical chemistry, immunochemistry and coagulation fields. Experience and care for the products guarantee the highest quality, flexibility and stability of the reagents. In Sclavo catalog there are over 600 codes useful to satisfy the major needs of the analysis laboratories. Bacteriology - Serology This product line provides to the laboratory kits for classical serology and bacterial identification, simplifying the work of cultures and serological analytical methods. Clinical Chemistry - Immunochemistry The Clinical Chemistry sector of Sclavo Diagnostics is described by the production and marketing of reagents and analytical systems. The reagents of Clinical Chemistry and Immunochemistry (Specific Proteins) are characterized by high flexibility and maximum quality. Traditional clinical chemistry methods are combined with the most technologically advanced specific protein products. Coagulation The Coagulation division includes a wide range of reagents, controls and calibrators essential for carrying out the routine of the most modern clinical analysis laboratories Pharmaceutics Sclavo holds the patent for over 20 years for the manufacture of glucose syrup used for Glucose Challenge Test (GCT) and for tests in the diabetic field. Safety is managed and guaranteed by a specific structure, internal and external, for the management of pharmacovigilance. Cosmetics The recent situation related to the pandemic from COVID-19 have seen Sclavo entering new fields of action producing sanitizing solutions, SclavoClean, on WHO formulation or its own formulation. In compliance with national and international regulations, Sclavo manages the safety linked to the manufacture and distribution of the aforementioned product through a specific supervisory body. SERVICES Sclavo Diagnostics offers various services, adaptable to customer needs: ▪ Third-party processing ▪ Lyophilisation ▪ Immunization ▪ Fermentation ▪ OEM - Private Label ▪ Validation of systems according to international CLSI protocols ▪ External Quality Control ▪ Development and industrialization ▪ Research CERTIFICATIONS SCLAVO Diagnostics International has adopted and maintains an excellent quality control system confirmed by ISO 13485 and ISO 9001 certification.