Q&R Canada
Q&R Canada Inc. specializes in providing comprehensive regulatory compliance services for drug products, medical devices, natural health products, cosmetics, and food in Canada. Their mission is to assist companies in achieving and maintaining compliance with Canadian regulations, ensuring safe and legal market entry and operation. With a team of experienced professionals with 10 to 20+ years of expertise, they offer personalized, expert guidance to protect and build their clients' brands and profits.
Industries
Nr. of Employees
small (1-50)
Q&R Canada
Services
End-to-end preparation of regulatory dossiers for drugs, natural health products and medical devices, and management of the review process with Canadian regulatory authorities.
Preparation and submission support for establishment licences (drug and medical device), representation during licensing inspections, and post-approval compliance management.
Design and management of QA systems, audits and self-inspections, document control, supplier evaluations, product release processes and routine QC activities.
Preparation of Validation Master Plans, protocol development and execution for analytical method validation, cleaning validation, equipment IQ/OQ/PQ, process and facility validation, and final reporting.
Review and approval of GMP documentation including master production documents, batch records and validation reports; development, gap analysis and implementation of Standard Operating Procedures.
Classification of products, preparation of NHP submissions (compendial, non-compendial, traditional, homeopathic), specification reports and assistance obtaining product and site licences.
End-to-end preparation of regulatory dossiers for drugs, natural health products and medical devices, and management of the review process with Canadian regulatory authorities.
Preparation and submission support for establishment licences (drug and medical device), representation during licensing inspections, and post-approval compliance management.
Design and management of QA systems, audits and self-inspections, document control, supplier evaluations, product release processes and routine QC activities.
Preparation of Validation Master Plans, protocol development and execution for analytical method validation, cleaning validation, equipment IQ/OQ/PQ, process and facility validation, and final reporting.
Review and approval of GMP documentation including master production documents, batch records and validation reports; development, gap analysis and implementation of Standard Operating Procedures.
Classification of products, preparation of NHP submissions (compendial, non-compendial, traditional, homeopathic), specification reports and assistance obtaining product and site licences.
Expertise Areas
- Health Canada regulatory submissions (drugs, NHPs)
- Medical device regulatory compliance and classification
- GMP compliance and quality assurance systems
- Validation and qualification (analytical, equipment, process, facility)
Key Technologies
- Analytical method validation
- Stability study protocols and data analysis
- Temperature mapping and environmental monitoring
- Equipment qualification (IQ/OQ/PQ)