Advanced Medicals Consortium Medical Regulatory Consultants

Advanced Medicals Consortium welcomes you to our web site! Our medical consulting company provides effective regulatory guidance through quality solutions. Read more about us here.

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.

Call or e-mail us today with your compliance concerns, requirements, or filings.

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. Our 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)

Our core areas of medical consulting expertise include: Regulatory Submissions; Computer System Validation for Equipment, Processes and Products; Quality System Requirements; Software Develeopment, Test, Integration and Compliance, Risk Assessment and Management; Human Factor Engineering; Corrective and Preventative Action; DFMEA, FMEA, Gage Reliability and Repeatability, Method Validations for Pharmaceuticals, Medical Devices and Combination Products; IT Network and Infrastructure Testing and Verification...; Contract Manufacturing in Class 10,000 Clean Room. Please click here to learn more details about our Core Expertise.

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