|GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Advanced Medicals Consortium has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network.
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
Certifications: 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)
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)
Regulatory Submissions: o 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) o Integration Verification & Validation "X Unit, Integration, and System Acceptance Testing "X IOPD/Q's "X Factory & System Acceptance Testing o Laboratory Systems (Chemistry, Assays, Automation & Robotics) o Full Validation cycle (Master Validation Plan) with complete validation documentation Quality System Requirements (QSR), cGxP's o Development, integration and training of clients staff with Quality System Requirements o Audits (first and second party) internal, external, pre-FDA inspections, ISO 9001:2000 o Medical Device (21 CFR 820), ISO 13485 o Finished Pharmaceuticals (21CFR 210, 211) o Biologics (21 CFR 600) o Human Cell & Tissue (21CFR 1271) Software Development, Test, Integration and Compliance (V&V) for Class II & III Medical Device Risk Assessment and Management, Hazard Analysis ISO 14971 & 16085 Human Factor Engineering (AAMI HE48 and FDA) Corrective and Preventative Action (CAPA) DFMEA, FMEA, Gage Reliability and Repeatability (G,R&R), SPC & ANOVA Method Validations for Pharmaceuticals, Medical Devices and Combination Products IT Network & Infrastructure testing and verification, penetration testing, vulnerability assessments for Internet, Intranet and Extranets Contract Manufacturing (Proto-types, small production up to 5000 units) in Class 10,000 clean-room