SALT LAKE CITY, UT--(Marketwired - Feb 14, 2017) - Achieving and maintaining FDA approval can be a tough challenge for life science companies. Especially for small to mid-size organizations that can't always support the internal personnel required to manage the vast array of compliance and quality demands placed on regulated companies. With the launch of ARCexperts, these companies have an opportunity to receive world-class audit, risk, and compliance consulting from a team of compliance experts that each brings more than 15 years of experience and most are recognized industry key opinion leaders (KOLs). Their services are designed to streamline the quality and compliance process for small to mid-size pharmaceutical, medical device, biotech and related life science industry companies. From securing proper product submissions, to launch and commercialization support, to audits, to assistance in building a healthy and validated quality management system (QMS) -- ARCexperts offers powerful and trusted advisors and services.
"The regulatory and quality system requirements that all life science organizations face increases every year and the requirements themselves continue to evolve and change," said ARCexperts CEO and Founding Partner Walt Murray. "ARCexperts helps these companies in assessing their current state, providing roadmap recommendations to secure approved product and technology submissions, regulatory body compliance and the team support to help maintain a validated QMS. These are the 'must-haves' of operating as a regulated company. With our assistance, these companies can operate confidently knowing these requirements and processes are manageable and maintained."
Regulatory Compliance Services:
ISO Standards, CE Mark Prep & Filing, FDA 21 CFR, 510K, EU Part 11, Canadian CMDCAS, Product Validation, Medical Device Directive (MDD), Good manufacturing Practices (GMP, Good laboratory Practices (GLP), Good Clinical Practices (GCP), Audits (QMS, supplier, customer...), Process Validation, Quality System Regulation (QSR), Clinical Evaluation Reports (CER), Standard Operation Procedures (SOP), Design History File (DHF), Supplier Quality & Purchasing Controls, Corrective Actions (CAPAs), Change Management Systems (CMS), Training.
Quality & Risk Mitigation Services:
Supply Chain Management, Enterprise Risk Assessment, Quality Management Systems, Improvement, Pre-post M&A Integration, Operational and Executive Leadership Structuring, Technology Exchange & IP Management, Laboratory Info Management System (LIMS), Standard Operation Procedures (SOPs), Pre-certification Audits, Document Control, Design Control, Manufacturing & Production Processes, Supplier Quality & Purchasing Controls, Corrective Actions, Enterprise Resource Planning (ERP), CLIA, Change Management Systems (CMS), Training.
"Our global customers depend on us to ensure that they can go to market efficiently with their products or services, knowing that they are not going to be surprised by receiving notices from any regulatory body that their operation and goods are not compliant," said ARCexperts COO and Managing Partner Leslie Norris. "ARCexperts helps regulated organizations by sharing the process of performing the audits, QMS development, standards and submission requirements, along with staff training in order to maintain a risk mitigated environment."
ARCexperts is an industry leading regulatory compliance and quality systems consulting firm that provides in-depth services to small and mid-size organizations in the pharmaceutical, medical device, biotech and related life science industries. Their consultants are globally recognized KOLs that frequently speak and present at global conferences. Their services are offered on either a by-project basis or as an on-going service providing Quality and Compliance as a Service (QCaS). For additional information on ARCexperts, call 1.801.878.9945, email firstname.lastname@example.org, email@example.com or visit www.arcexperts.com.