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comes compliance services (CCS) is an independent, premier, boutique and highly experienced consulting company specializing in simplifying and streamlining EMA, FDA, ICH and GHTF quality systems, validation and regulatory compliance requirements. CCS is managed by Markus Roemer. CCS is the head management of a partner and alliance network called CCS network, in which well recognized companies deliver products and services to the regulated industries. CCS is the founder and sponsor of IT Pharma Validation Europe organisation, one of the largest validation networks in Europe, which is a world-class recognized organisation in regulatory compliance, validation, project management and consulting services. Our services encompass the entire compliance and validation project life cycle, and a complete range of IT project services including ERP, MES, LIMS, DMS, eQMS, eCTD, eValidation, Test Management Systems and all types and brands of IT and application systems used in regulated laboratories, manufacturing or medical device production. We manage and execute full validation projects, including development of validation policies, SOPs, master plans and requirements; development and execution of installation qualifications, operational qualifications and performance qualification; and the performance of individual tasks associated with a client’s validation efforts. We are dedicated to the pharmaceutical, biological, biotechnology, healthcare and medical device industry. Our consultants are themselves from the industry and have the education, knowledge and hands-on personal experience and validation expertise needed for the challenges facing today’s pharmaceutical operations. Our mission is to contribute to the success of our clients by providing them with Compliance Management Solutions that will improve their ability to develop, manufacture and deliver drugs and medical devices to market. We provide excellent project leaders to achieve on-time, on-budget, successful projects. Our project leaders furnish initiative and project consultation to organize and execute work needed to achieve the results expected by our clients. About 80 percent of our business is repeat-business.
Comes (genitive: comitis) is the Latin word for comrade, companion, associate, partner. The word comes derives from com- "with" + ire "go."
Our satisfaction guarantee: You get 12 months of free expert advice to help prepare and protect you when any auditor or inspector shows up. If we don't meet our agreements with you or the Codes of Ethics of the professional societies to which we belong to you will also get 10 days of free follow-up consultancy. If you receive any critical audit findings related to our work or advice (not covering self-inflicted or third-party involvements) you will also get a free follow-up consultancy for corrective actions.
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location: comes compliance services
CCS is the one and only consulting firm in the regulatory sector providing a live proposal request:
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Are you ready to turn compliance into competitive advantage? With our comprehensive services, you get long-term benefits and bottom line results. Contact us today.
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