Welcome to the World of CCS:

Minimize risks, lower costs, and speed up your time to market with strategies, policies, and controls that improve your compliance and contribute to your bottom line. Everything we do is backed by broad-based expertise, problem-solving methodology and smart solutions.

CCS Experts work with you to look at the organisation holistically in the light of best practices and your existing policies, procedures, processes, and applicable regulations.

From that starting point, we will help you plan a risk-based route that lets you take consistent steps to achieving the results you need. Then we help you take those steps, using proven services and methods to gain the benefits of a consistent, value-added approach to compliance.

Our Compliance Proposals should fulfill your needs and your professional expectations - even at this early stage of a possible project work.

We are analysing your project requirements for resource management, technical and procedural needs, scheduling, and regulatory compliance issues.

We will create together with you an inexpensive and flexible road-map to compliance. We assist you in getting ahead with your business challenges, clear project success and personal career.

A project with us can be devided into several project sections with clear performance milestones or sub-projects. You define amount and area of work, project structures, team setup, and expected deliverables.

As an enabler of innovative technology and tools, CCS implements and uses different solutions for modern compliance management.

We offer cost-effective, readily implemented compliance options that rank among the best available on the market: CaaS - Compliance as a Service.

Our services will be demonstrated through practical examples and explained and implemented by experienced professionals; for example www.auditservicecenter.com or HP Quality Center.

Discover with us the easiest way to comply with regulations. Our Compliance Project Teams are composed of leading Subject Matter Experts.

CCS is located in Ravensburg, Germany. With our partners in the UK, France, Austria, Switzerland, Canada, and US we find a special set up for every project dedicated to the regulated industry.

Within the CCS Network we are able to find the right person for the right work scope and area. CCS Network projects make the difference: Consultancy with Subject Matter Experts on demand.

Are you determined to kick off a compliance program in order to gain a competitive edge? For further information, download our company brochure: Company Brochure (PDF - 0,5 MB)

Our comprehensive package of sector-specific services will enable you to derive long-term benefits and bottom line economic results.

We are dedicated to the pharmaceutical, biological, biotechnology, healthcare and medical device industry. About 80 percent of our business is repeat-business.

Our consultants are themselves from the industry and have the education, knowledge and hands-on personal experience and 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 products to market.

We are bringing our services of excellence to four of the top 5 pharmaceutical companies and are ranked as a preferred supplier to several global players.

comes compliance services is an independent, highly experienced, and premier consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements.

At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more pro-active and risk-based approach to quality assurance and validation backed by proven expertise and tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness: CaaS - Compliance as a Service.

comes compliance services offers different concepts, strategies, and methods for compliance management:

  • Quality Management consultancy and PQM integration (ICH Q8/Q9/Q10; QbD; PIC/S Aide-Memoire PI 038-1)
  • IT and System Validation (ISPE GAMP 5)
  • Audit Service Center (third party / shared audit programs)
  • Vendor and Outsourcing Assessments (Outsourced Activities)
  • Project / Program Management (ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry)
  • Pharma 2.0 implementation (EBR, Paperless Lab, Data Warehouse)
  • Network / Infrastructure Qualification, eValidation, Qualification, Verification, Review services
  • Special topics like Spreadsheet or ERP validation, GxP compliant development, Document Management Systems (MS Sharepoint platform), etc.
  • Qualified Person / Experts’ support & compliance program implementation
  • CAPA, OOS, deviation management support, training & learning management
  • Regulatory inspections / audit preparation and escort services
  • Quality management structures & methods (e.g. QA operations, communication & reporting, trending)

Any project or program will be implemented by our experienced CCS Team. We are providing best practices and services for modern Quality Management Systems: concepts - planning - training & coaching - implementation - on ongoing support and monitoring - reporting. Also we provide so called Focused Solution Packages as special deals and predefined packages for rapid implementation.

If you require more details on support and services, go to the CCS Competence Center.

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Take a look at our partner and solution network, pricing options, procedures, tool management, proven record of success, and our unending dedication to customer satisfaction to see why our clientele relies on CCS.

Start your Live Proposal Request right now. Contact us today.

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comes (genitive: comitis) is the Latin word for comrade, companion, associate, partner.

The word comes derives from com- "with" + ire "go."

when IT comes to compliance....