Advanced Medicals Consortium

Overview

Advanced Medicals Consortium's vertical integration allows our clients the benefit of industry expertise in the Medical Device, Pharmaceuticals and Biotechnology domains. Our qualified national associates have experience and expertise communicating directly with the FDA regarding regulatory guidance, medical device submissions and post-marketing surveillance. We assist our clients through all phases of the regulatory process. Our team provides timely, concise and valuable expertise to clients required to participate with FDA, EU (EMEA & GHTF), Canadian Health and Japanese Ministry of Health agencies for their regulatory submissions.

All of Advanced Medicals Consortium's associates participate in professional organizations to provide ongoing training & education to clients, capitalize on new strategies and technologies, and maintain a strong networked community of industry experts

Standards & Methodologies

FDA - IDE, HDE, HUD, NDA, 510(k), PMA & Combination products o EU - CE, IVDD, Design Dossier, MDD o Canadian Health Class I-IV, CMDR o Japanese Ministry of Health (MHLW)  Computer System Validation for Equipment, Processes and Products o IEEE, ISO/IEC, ISPE (GAMP4), SEI (Security, Software Development, & Auditing)

Qualifications, Certifications, Accreditations & Licenses

Advanced Medicals Consortium's colleagues are degreed professionals and have recognized certifications within these organizations: ▲ American Society for Quality (ASQ) ▲ American Society for Testing and Materials (ASTM) ▲ Carnegie Mellon University's Software Engineering Institute (SEI) ▲ Institute of Electrical and Electronic Engineers (IEEE) ▲ International Society of Pharmaceutical Engineers (ISPE) ▲Parenteral Drug Association (PDA) ▲Regulatory Affair Professional Society (RAPS)