Many companies doing business in regulatory environments treat compliance like another obstacle to success. ARCexperts helps companies that live in regulatory environments understand that compliance is actually a tool that can give them a competitive advantage. Our compliance strategies cover the entire range of processes from product design, manufacturing, shipping and storage. Our experts ensure life science companies meet FDA approval to manufacture and sell their products globally.


Our Regulatory Compliance services include but are not limited to:


Internal Auditing

FDA 21 CFR

510 (k)

EU Annes 11

Canadian CMDCAS

Product Validation

Medical Device Directive (MDD)

Good Manufacturing Practice (GMP)

Good Laboratory Practice (GLP)

Good Clinical Practice (GCP)


Our industry experts empower life science companies to use risk-based thinking to ensure all risk-related hazards are considered throughout the life cycle process from beginning to end.  We help life science companies meet their risk management and assessment requirements and make strategic and data-driven decisions to improve and reduce risk. As a global leader in risk management consulting, we provide risk-based decision making and appropriate analytical tools that help improve overall quality.


Our Quality & Risk Management services include but are not limited to:


Supply Chain Management                                     
Enterprise Risk Assessment                                    
ISO Standards                                                            
CE Mark                                                                          
Quality Management Systems                                
Performance Improvement                                    
Pre-post M&A Integration                                       
Operational Mgmt Structuring                               
Technology Exchange & IP Management             
Laboratory Info Management System (LIMS)

​Standard Operation Procedures (SOP) 





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Pre-certification Audits
Document Control
Design Control
Manufacturing & Production Processes
Supplier Quality & Purchasing Controls
Corrective Actions
Enterprise Resource Planning (ERP)
CLIA
Change Mangement Systems (CMS)
Training

Process Validation

Quality System Regulation (QSR)

Clinical Evalutation Reports (CER)

Standard Operation Procedures (SOP)

Document Control

Design Control

Supplier Quality & Purchasing Controls

Corrective Actions

Change Management Systems (CMS)

Training

SERVICES TO THE LIFE SCIENCE INDUSTRIES