Business Details
26 Years
experience
Trusted Engineering Solutions in Oakville, ON
Sage Engineering Service has been delivering quality engineering solutions for over 25 years. Our team combines industry-experienced engineers, technicians, and project management professionals to serve regulated industries globally. We prioritize client collaboration, integrating our experts with client teams to ensure project success. With strategic partnerships, we provide flexible full-service teams tailored to project demands. Our core values of quality, teamwork, and commitment guide every project. We maintain a consumer safety mindset while pursuing fit-for-purpose solutions through continuous improvement.Our consultants actively involve clients in decision-making and draw from specialized knowledge to deliver results. We emphasize accountability, supporting projects through completion and beyond while focusing on problem-solving. Our expertise spans equipment design, facility engineering, compliance, and validation across pharmaceutical, medical device, and nutraceutical sectors. We stay current with regulatory changes to ensure compliance with FDA, EMA, and other authoritative standards.
Services
Project Management
Compliance & Validation
Equipment Engineering
Facility Design
Automation Solutions
Serialization Services
LEAN Improvement
Radiopharmaceutical Solutions
Details
- Year established: 2000
Highlights and features
- We offer 25+ years of specialized experience in regulated industries
- Our team integrates directly with client project teams
- Strategic partnerships enable flexible full-service delivery
- ISO-certified quality management processes
- Commitment to regulatory compliance and continuous improvement
Associations and certifications
- Association of Professional Engineers of Ontario
Services
Project Management
We provide comprehensive project management services for regulated industries. Our approach emphasizes end-to-end delivery while maintaining flexibility to meet specific client needs. Our team manages time, scope, and budget constraints while ensuring compliance with industry regulations. We support pharmaceutical, food and beverage, nutraceutical, and medical device projects through all phases from initiation to closeout.
Compliance & Validation
Our compliance experts ensure adherence to FDA, EMA, and other regulatory standards. We develop validation master plans, execute qualification protocols, and implement quality management systems. Services include change control, non-conformance resolution, and computer systems validation across pharmaceutical, medical device, and health and beauty industries.
Equipment Engineering
We specialize in equipment design, installation, and qualification for regulated environments. Our team provides factory acceptance testing, commissioning, and validation services. We support facility expansions and process improvements with specialized expertise in hot cells, isolators, and clean room technologies for radiopharmaceutical manufacturing.
Facility Design
Our facility design services include greenfield projects, refurbishments, and process optimization. We conduct capacity analysis, spatial planning, and utility specifications while maintaining GMP compliance. Our team integrates material flows, people movement, and utility systems to create efficient manufacturing environments for pharmaceutical and nutraceutical clients.
Automation Solutions
We implement automation systems for regulated manufacturing environments. Our solutions include control system validation, data integrity management, and integration of automated equipment. We ensure compliance with 21 CFR Part 11 and other regulatory requirements while improving process efficiency and product quality in pharmaceutical production.
People
John Doe
Lead Project Manager
20+ years of experience in pharmaceutical engineering projects. Specializes in facility expansions and regulatory compliance. Proven track record in managing complex validation programs for global clients.
Jane Smith
Validation Director
Certified validation expert with 15 years in GMP compliance. Leads teams in executing validation master plans and computer systems validation. Recognized industry speaker on data integrity and regulatory trends.
Questions
What industries do you specialize in?
We specialize in pharmaceutical, medical device, nutraceutical, and health and beauty industries.
Are your engineers certified?
Our team includes professionals authorized by the Association of Professional Engineers of Ontario.
Do you work internationally?
We serve clients across North America and internationally through strategic partnerships.
What validation services do you offer?
We provide full validation services including IQ/OQ/PQ, CSV, and regulatory compliance validation.
How do you ensure project success?
We use proven project management methodologies while maintaining flexibility to meet client-specific needs.
