For over 20 years, IQC are the first choice for compliance consulting services. We provide flexible, scalable, Quality, Regulatory expertise to biotechnology, pharmaceutical, and medical device companies. We help resolving compliance issues and responding to an FDA 483, warning letter or product recall. Our portfolio of services contains quality systems implementation and upgrades?, regulatory compliance for computerized systems, production and laboratory equipment. Definition and execution of IT ? Validation Policies (IT ? Validation and IT ? Security) for LIMS- and Lab-Automation systems and Robots. Execution of 21CFR Part11 compliance projects. Regulatory compliance status analysis. Inspection preparation / Inspection assessment. Support for defense and correction of compliance deviations of regulatory authority inspections. In the area of Contract Manufacturing Assessment and Support we assess and audit existing partners to identify and correct potential gaps, ensure alignment with Corporate Quality System, drive standardization of templates and confirm suitability for intended use, design and manufacturing quality.