Regulatory Affairs  Quality Systems  Clinical Research

NW Clinical Research Group
NW Clinical Research Group
NW Clinical Research Group

Compliance - Achieving and maintaining regulatory approvals

    

A necessary step to retaining regulatory approvals and conducting clinical trials is compliance to all US and foreign regulations.
 
NWCRG provides consultation and implementation of quality systems, ISO certification, CE Marking, and readiness for FDA and Notified Body inspections.
 
 

 

Compliance Services
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Development and Review of Labeling and Advertising Materials

Design and Implementation of Quality Systems (QSR, EN Standards, and ISO certification)

Quality System Training, Audits and Audit Program Implementation

Facility Registration and Device Listing

Quality Assurance Unit Auditing of GLP Animal Laboratories

Protocol and Test Report Standardization and Systems

Preparation for FDA Inspections

Preparation for Notified Body Inspections

Medical Editing & Technical Writing

Publications

Literature Review

Standard Operating Procedures