Quality Certificates and Standards Home > Quality Certificates and Standards Injectable Plants GMP certificate Approved by the following regulatory agencies: FDA (USA) AEMPS (Spain) ANVISA (Brazil) MHRA (UK) KFDA (Korea) Russian Agency (Russia) Kazajstan Agency (Kazajstan) Bielorusian Agency (Biolorusia) Turkish Agency (Turkey) Gulf Cooperation Council (GCC) Manufacturing products with CE marking Madrid Excelente license Quality Standards OHSAS 18001 ISO 14001 ISO 14644-1, -2, -3 and -4, regarding cleanrooms CPMP/ICH/2736/99-Q1A (R2), regarding stability testing EAL-G19, USP (latest edition), UNE-EN 45501, CGA-ENAC-LE, LEA-ENAC-LC, regarding calibration ISO 9000-3, and 21 CFR (FDA) ISO 13408-1, regarding media-fill validation ICH Q8, Q9 and Q10, regarding quality systems for pharmaceutical products Solid Forms Plant GMP certificate We have received approval from the following regulatory authorities: FDA (USA) AEMPS (Spain) ANVISA (Brazil) COFEPRIS (Mexico) NIHS (Japan) Gulf Cooperation Council (GCC) The Center for Examinations and Tests in Health Service (Belarus) Pharmacy and Poisons Board (Kenya) Alcalá de Henares Vía Complutense, 140 28805. Alcalá de Henares Madrid, Spain Madrid Julián Camarillo, 35 (Entry: Rufino González, 50) 28037. Madrid Madrid, Spain San Sebastián de los Reyes Paseo de Europa, 50 (Carretera Madrid, 14Y) 28709. San Sebastián de los Reyes Madrid, Spain Please contact: Business Development roviservices@rovi.es // Contract Manufacturing Services Tel.: +34 91 119 08 18 CONTACT US CONTACT US PRIVACY POLICY TERMS AND CONDITIONS LEGAL NOTICE COOKIE POLICY EXERCISE OF RIGHTS GDPR LABORATORIOS ROVI Copyright © 2020 Laboratorios Farmaceuticos Rovi S.A. - All Rights Reserved This website uses technical cookies belonging to us which are indispensable to browse this website. The website owner, who is responsible for the processing of the cookies, and their contact data may be accessed in the Legal Notice. If you would like more information on the use of cookies on this website, click here. Cookie Policy - Impressum ACCEPT ALL DISMISS PREFERENCES