FDA compliance - regulatory strategy development, clinical trial development/ management, cGMP compliance, on-site audits, validation (process, software and sterilization) and 510(k)/PMA/ANDA/NDA submission services
ISO compliance - ISO 9000:2000, ISO 14000, ISO 13485:1997 (EN46001), EN540 and Quality Systems
Crisis Intervention - FDA audit response (483), warning letters, and product recalls
European compliance - CE mark, Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD)
Other industry-related services - HACCP, In-Vitro Diagnostic Research and Development, U.S. Agent (for non-U.S. companies), sales force performance improvement, and marketing assistance
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