Saturday, 27 November 2021 English Español Català COMPANY PRODUCT & SERVICES THE GROUP OUR QUALITY NEWS CONTACT CGMP Compliance Home > Our quality > CGMP Compliance A specialized staff supervises the compliance with cGMP standards requirements for all the organization. This team manages the different elements of the quality system, including: Validation Master Plan Internal Audits Investigation of process deviation Complaints and OOS Change controls SOPs Training Raw material suppliers’ qualification Our facilities are regularly inspected by our clients and have been routinely inspected by different authorities FDA inspected since Latest FDA inspection Other inspections Activity M. CATALANA 1984 May 2018 AEMPS (Sept 2017),K-FDA, Japanese Accreditation, Russian H.A. (July 2017) Generics / CM M. CANTABRA 2010 October 2015 AEMPS (Jan 2018), TGA, Japanese Accreditation Generics / CM COPRIMA 2001 February 2016 AEMPS (Dec 2018), Cofepris, Japanese Accreditation Generics MOEHS BCN July 2019 July 2019 AEMPS (Jan 2017), Japanese Accreditation Generics / CM BENECHIM 2013 February 2016 AFMPS-Belgium (Jan 2018), Japanese Accreditation Generics / CM NORCHIM 1989 June 2017 AFSSAPS-France (Dec 2018), Japanese Accreditation Process Research CM C.F. BERG 2002 June 2018 BfArM-Germany (Dec 2017), K-FDA, Japanese Accreditation Generics / CM PROTEOS BIOTECH AEMPS (May 2017) Biotechnology · ICH Q7 compliance · Compliance to USP, EP, JP,ND · More than 30 CEPs Issued · 28 USDMF filed at the FDA Pol. Ind. Cova Solera c/ Roma, 8-12 08191 Rubí, Barcelona (Spain) T +34 93 586 05 20 | Fax +34 93 588 85 13 info@moehs.es Home Privacy and Legal Advice Contact Work with us

Saturday, 27 November 2021 English Español Català COMPANY PRODUCT & SERVICES THE GROUP OUR QUALITY NEWS CONTACT Technical Assistance Home > Our quality > Technical Assistance We support our customers with the Technical Assistance that the Quality Unit provides: Analytical methods Working standards Formulation Marketing license applications Regulatory compliance Product customization Pol. Ind. Cova Solera c/ Roma, 8-12 08191 Rubí, Barcelona (Spain) T +34 93 586 05 20 | Fax +34 93 588 85 13 info@moehs.es Home Privacy and Legal Advice Contact Work with us