GMP & Quality Services
DSA Consultants have been leaders in Canadian NHP Site Licensing since the regulations came into force in 2004. We manage all aspects of the licensing process from application to inspection and post-approval compliance with GMPs.
A DSA Consultant can assist you with any function of GMP Compliance. Our Consultants will work with you to ensure that your NHP shipments have met the requirements of the Canadian NHP GMPs. We can act as your QA/QC department (Quality Assurance Person or QAP) and review production documents and analytical test results to support product releases. If all documents are satisfactory, your Consultant will promptly release products for sale in Canada. We can handle your product releases on a full-time, part-time, or on an as-needed basis to cover staff shortages due to vacation or other absences.
For clients that are new to GMP compliance requirements, our Consultants will work with you to develop GMP programs including preparation of SOPs (Standard Operating Procedures). We will work with you to help prepare your staff and facility to pass a Quality Audit (Quality Assurance Report) and eventually a Health Canada GMP Inspection. A DSA Quality Consultant offers valuable expertise for review and approval of batch deviations, reprocessing and rework. Using our quality services at the release stage helps identify quality issues before the product is released for sale; so that costly recalls can be avoided.
Contact us to find out more about our regulatory consulting services or download a free copy of our DSA Whitepaper on marketing a health care product in Canada.