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Safety assessment - Manufacturer Producer - Romania

RomaniaManufacturer/producer
  1. PERFECT CARE DISTRIBUTION SRL

    Romania

    Perfect Care is engaged to offer a wide range of services for Contract Development and Manufacturing (CDMO) as well as high quality proprietary cosmetic and medicine products. ISO 9001: 2015 ISO 22716: 2007 - Cosmetics GMP ISO 13465: 2016 - Medical Devices GMP, EU MDR regulation compliant. Services we offer: Formulation - Do you already have a finished formula or would you like one to be developed to suit your concept? We meet your wishes through: - the uniqueness of our know how in concepts’ creation - our well equipped laboratory that matches the energy and creativity of our Research and Development team - our desire to be innovative Regulatory Service - We want to make sure that your products meet the regulatory compliance: - challenge tests, efficacy tests, safety assessment and other clinical studies - building up the files containing information about the products - we will support you with the correct declaration in compliance with the Cosmetics Directive, EU MDR & MDD Directive for Medical Devices, as well as with any documentation required for EU & outside EU registration of products Production - an industrial site devoted to manufacturing creams, vaginal ovules, suppositories, oral solutions, serums, lotions, milks etc. - compliance with GMP guidelines - filling in many types of primary packaging (suppositories, sachets, tubes, airless, bottles, sample tubes, jars etc.)

  2. BEST MANUFACTURING

    Romania

    BEST MANUFACTURING continues the tradition of 100 years of UMUC SA in execution of pressure vessels, heat exchangers (evaporators, coolers, condensers); Trails of technological pipelines; Welded steel structures CERTIFICATIONS: ISO 9001 : 2008 ; AD 2000 MERKBLATT HP 0 ; DIN EN ISO 3834-2 ; OHSAS 18001 : 2007 ; SR EN ISO 14001 : 2005All our equipment is designed, manufactured and tested in accordance with this European Directive for the supply of pressure equipment and is CE marked when applicable. It is backed up by comprehensive technical documentation for quality and safety, including: • Operating and Maintenance Instructions• Pressure Testing Certification• Material Certification• Welder Qualifications and procedures• Non-Destructive Testing Reports• Third Party Inspection Reports• Risk Assessment and Method StatementsWhere applicable mechanised equipment is design in accordance with the Supply of Machinery Directive and CE marked accordingly.The system of quality in BEST MANUFACTURING

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Safety assessment - Manufacturer Producer - Romania

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