Compliance Services
Providing five core services to the regulated industry in the following areas:
Our colleagues are degreed professionals and have recognized certifications within these organizations:
ASQ American Society for Quality
ASTM American Society for Testing and Materials
SEI Carnegie Mellon University’s Software Engineering Institute
IEEE Institute of Electrical and Electronic Engineers
ISPE International Society of Pharmaceutical Engineers
PDA Parenteral Drug Association
RAPS Regulatory Affairs Professional Society
- System Integration, Commissioning and Qualification, Performance Qualifications
- Computer System Verification & Validation , Security, Network Infrastructures
- Regulatory Compliance, Documentation & Submissions for New Drugs, Combination Products and Medical Device applications
- Manufacturing facilities, Environmental Controls, Computer Systems, Process and Product Auditing
- Contract Manufacturing, Proto-type development for Drugs, Medical Devices and Laboratory Robotics
All business principles and associates
are committed to providing exemplary services to our clients by utilizing known quality initiatives, ethical business practices, recognized industry standards, including ASTM, AAMI, IEEE, & ISO/IEC; recognized guidance principles, including FDA, GHTF, ICH, ISO, & ISPE, along with all applicable regulatory requirements, for National & International Institutions, Research & Development facilities and Manufacturing businesses as required to maintain a state of compliance.
Years of Industry Expertise
Advanced Medicals Consortium business collaboration brings many years of industry expertise and experience together in one place providing each of our client’s access to an unparalleled breadth of knowledge specific to the regulatory environment.