Achieving Regulatory Compliance in Canada: Your Pathway to Success
At Zes Q&RA, we specialize in providing expert guidance on Regulatory Compliance in Canada. Our dedicated team of regulatory experts provides specialized submission support services, guiding clients seamlessly through every stage of the regulatory process, from initial submission to ongoing maintenance. We cater to both domestic and international needs, ensuring your products gain timely access to their respective markets, globally.
Achieving Quality and Regulatory Compliance: Our Expertise
Leveraging our extensive experience in regulatory consulting, we excel at crafting customized quality systems tailored to your unique requirements. We address import challenges, conduct meticulous quality evaluations, and design bespoke solutions that not only meet but exceed regulatory expectations. Partner with us to develop a robust quality system that ensures smooth operations, unwavering regulatory compliance, and exceptional product integrity.
As your trusted regulatory compliance in Canada, we are committed to developing a quality system that not only meets but exceeds expectations.
REGULATORY
Pharmaceuticals / OTC
- Regulatory Strategy / Expert Review
- New Product Submissions – IMPD / CTA / IND / NDS / NDA / ANDS / ANDA
- Lifecycle Submissions -CTA-A / CTA-N / NC / SNDS / sNDA / SANDS / sANDA
- Deficiency Response Support
- DIN Applications
- DEL Applications / Amendments / Renewals
- CMC Review / GAP Analysis
- Label Review and Product Monograph Updates
- API-DMF and CEP Applications / Review
- Regulatory Agency Interface
Medical Devices
- MDEL Applications
- MDL Applications
- Device Classification (Class – I, II, III, IV)
- Annual License Renewals
- Label Review
Natural Health Products / Dietary Supplements
- Site License Applications
- NHP Applications
- Label Review
- IRN Response Preparation / Submission
- Literature Search / Review
Cosmetics
- Notifications
- Review of Ingredients with Cosmetics Hot List
- Label Review
QUALITY
Pharmaceuticals / OTC
- Audits and Self-inspections
- Health Canada Audit Support
- Manufacturing Sites (Foreign & Domestic) Qualification
- cGMP GAP Analysis and Quality Remediation
- SOP Preparation / Review
- Quality Management Systems – Development and Implementation
- Stability Program Support
- cGMP, GDP, and QMS Training
- Temperature Mapping (Winter and Summer Mapping)
- Transportation Procedures and Documentation
- Recall Management and Product Complaint Support
- Review documentation and Release of drug products to the Canadian Market
Medical Devices
- Audits and Self-inspections
- cGMP GAP Analysis
- SOP Preparation / Review
- Health Canada Response Support
- Release of Medical devices to the Canadian Market
Natural Health Products / Dietary Supplements
- Audits and Self-inspections
- cGMP GAP Analysis
- SOP Preparation / Review
- Health Canada Response / IRN Response Support
- QMS Program Support
- Release of NHP to the Canadian Market
- Specification Preparation
- Stability Program Support
- Formula Reviews
Cosmetics
- Formula Reviews
Pharmacovigilance
- Complaint Assessment
- Literature Search / Review
- Annual Summary Reports
- SUSAR / DSUR Review & Submission
- ADR Filing
Choose Zes Q&RA for Unparalleled Regulatory Compliance Expertise in Canada
Delivering Comprehensive Regulatory Compliance in Canada
Our mission is to deliver comprehensive solutions that align with the stringent regulatory requirements in Canada. We are committed to providing accurate information, conducting meticulous assessments, and offering valuable recommendations. As a leading firm among regulatory consultants in Canada, Zes Q&RA ensures our clients receive cost-effective solutions tailored to their specific Quality and Regulatory needs.
Catering to All Business Sizes
Zes Q&RA prides itself on a team of regulatory experts with extensive experience serving clients of all sizes, from startups to large corporations. Whether you are navigating the complexities of regulatory consulting in pharma or need assistance from a regulatory compliance services inc in Canada, our team is equipped to support you. We offer a variety of services designed to enhance quality and regulatory compliance within your organization.
Commitment to Excellence and Integrity
At Zes Q&RA, we are dedicated to maintaining the highest standards of excellence and integrity in all our services. We understand the challenges of regulatory compliance in the dynamic Canada market and strive to provide our clients with the best possible guidance to ensure success and compliance.
Navigate Canadian Regulatory Compliance with Confidence: Zes Q&RA, Your Trusted Partner
When it comes to regulatory compliance in Canada, trust the experts at Zes Q&RA. Contact us today and discover how our comprehensive services can help your business thrive in the Canadian market.
We are committed to achieving and maintaining the highest standards of excellence in all aspects of our services, from regulatory support to quality assurance consulting.
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(+1) 437-606-0004
inquiries@zesqra.com
1123 Barr Crescent, Milton, ON L9T 6Y3
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