Regulatory

Regulatory

Our expertise in Regulatory Affairs enables us to meet the growing standards of the world’s Health Agencies and most demanding costumers.

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 our products’ safety, efficacy and quality to regulatory authorities worldwide.

• 2 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