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Boenigk Consulting GmbH is a service provider for Interim Management, Consulting, Project Management and Program Management of Compliance Projects in Pharmaceutical, Biotechnology, Medical Device, Cosmetic and Food Industries. Boenigk Consulting GmbH is an international team of experts from various disciplines. It's portfolio ranges from establishing, re-designing and improving Quality Management Systems with integrated Risk Management (ISO 14971 , ICH Q9). Another core expertise is implementing and driving Quality System Compliance Programs specifically with regard to FDA inspections and other international authorities. Boenigk Consulting GmbH is offering Mock Audits with former FDA inspectors, inspection readiness programs, support before during (i.e. with a professional interpreter, organization of front and back office) and after inspections and audits. Further service is provided regarding crafting of response letters on audit findings, non-conformance reports, FDA 483 observation and Warning Letters and communication with authorities. The Boenigk Consulting GmbH team will also support clients implementing Lean Management tools and provide Regulatory Affairs and FDA registration services. The service portfolio is rounded by training coaching of their client's employees / personnel.
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