Our Services Include: Regulatory and strategic planning Audits of foreign and Canadian facilities Medical Device Establishment facility design MDEL set up consultation and customized training MDEL Attestations Writing Standard Operating Procedures (SOP’s) and Quality Manuals Guidance on Medical Device site Establishment Licenses (MDEL) process and inspections Liaison with Health Canada and International Regulatory Authorities for Inspections, audits and submissions Pre-inspection preparation and planning Manage and attend Health Canada Inspections Prepare post-inspection corrective action responses Complaints and Mandatory Problem Reporting Guidance on Medical Device License (MDL) Submissions/applications Application support during regulatory review Label and advertising review Guidance on regulatory compliance issues Regulatory Affairs Pharmaceuticals Medical Devices Natural Health Products Quality Assurance & Quality Control Contact +1 (204) 296-4449 info@rlspharmaservices.com Let’s Get Started Are you ready to work with our compliance specialists? CONTACT US
