About Us Life Science Performance Products Contract Manufacturing Products Regulatory News Contact EN REGULATORY REGULATORY Our expertise in Regulatory Affairs enables us to meet the growing standards of the world’s Health Agencies and most demanding customers. MENADIONA’s Regulatory Affairs Department staff, has wide expertise in dealing with diverse requirement-based scenarios across the world, and provides on a daily basis, scientific data supporting product safety, efficacy and quality to regulatory authorities worldwide. • 4 Certificates of Suitability (CEPs) granted by the European Pharmacopeia • 19 DMFs submitted to National Regulatory Authorities in 40 countries. Algeria, Argentina, Austria, Bangladesh, Belgium, Biolorrusia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kosovo, Maccedonia, Mexico, Morocco, Netherlands, Poland, Portugal, Russia, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, USA, Ukraine. QUALITY MANAGEMENT MENADIONA is a full cGMP compliant manufacturer of APIs, therefore, our quality assurance department is a fundamental and principal aspect in our organization. Our Quality System Management guarantees the consistent high quality of production through strict cGMP compliance. REACH Since MENADIONA is a European Producer, we are fully compliant with REACH requirements. Accordingly, all our products are registered and meet the May 2018 REACH deadline. AUTHORITIES & CLIENT AUDITS MENADIONA’s manufacturing sites operate under cGMP conditions and have been successfully inspected with excellent track records by relevant regulatory authorities and most recognized pharmaceutical companies. MENADIONA receives more than 20 Authorities and Customer Audits per year accomplishing their highest requirements. MEMBERS OF SECTOR ORGANIZATIONS MENADIONA participates proudly as a member of national and international organizations. - AFAQUIM: Asociación Española de Fabricantes de Productos de Química Fina. - FEDEQUIM: Federación Empresarial Catalana del sector Químico. - FEIQUE: Federación Empresarial de la Industria Química Española. - PIMEC: Petites i Mitjanes Empreses de Catalunya. - AMCHAM: American Chamber of Commerce. - IQS: Fundación Empresas IQS (Institut Químic de Sarrià). - Cambra de Comerç de Barcelona. Regulatory & Certificates Your trusted European manufacturer in specialty chemicals ABOUT US Who we are History & Figures Manufacturing Sites Corporate Social Responsibility (CSR) PRODUCTS Life Science Performance Products Contract Manufacturing GET SOCIAL Address: Pol. Ind. Mas Puigvert, s/n - 08389 Palafolls - Barcelona - Spain Copyright © 2018 Menadiona / +34 93 764 07 11 / menadiona@menadiona.com Quality policy | Privacy policy