Business Details
26 Years
experience
Your Trusted Engineering Partner in Oakville
Sage Engineering Service is committed to delivering quality engineering solutions through collaborative teamwork with clients. With over 25 years of specialized expertise in radiopharmaceuticals, we provide comprehensive engineering, compliance, and validation services for regulated industries. Our approach integrates client project teams with seasoned professionals, ensuring alignment with quality, safety, and regulatory standards. Strategic partnerships enable full-service project execution, while our core values of quality, teamwork, and commitment guide every solution. Our team combines 15 - 41 years of industry experience in pharmaceuticals, medical devices, and nutraceuticals, offering tailored support from design to validation.We prioritize consumer safety, continuous improvement, and fit-for-purpose outcomes, supported by a culture of professional development and accountability. Our services span facility expansion, automation, serialization, and LEAN methodologies, addressing complex challenges in regulated manufacturing environments. Authorized by the Association of Professional Engineers of Ontario, we uphold the highest standards of professional engineering practice. Client success drives our dedication to problem-solving, accountability, and long-term partnerships. With a global footprint serving North America and international markets, we deliver cost-effective, timely solutions that meet evolving industry demands.
Services
Project Management
Radiopharmaceutical Engineering
Compliance & Validation
Facility Expansion
Automation
Details
- Year established: 2000
Highlights and features
- Over 25 years of specialized experience in radiopharmaceutical engineering
- Strategic partnerships for full-service project teams
- Core values of quality, teamwork, and commitment
- Experienced professionals with 1541 years in regulated industries
- Client-integrated approach for tailored solutions
Associations and certifications
- Association of Professional Engineers of Ontario
Services
Project Management
We provide end-to-end project management for regulated industries, ensuring efficient execution from feasibility studies to handover. Our approach tailors processes to client needs, covering time, scope, and budget management while maintaining compliance with pharmaceutical, medical device, and nutraceutical standards.
Radiopharmaceutical Engineering
Specialized engineering for radiopharmaceutical manufacturing, including hot cells, shielded isolators, and clean rooms. We ensure compliance with radiation safety and aseptic requirements, offering site evaluations, pre-design packages, and validation to meet global regulatory standards for quality and safety.
Compliance & Validation
Our compliance services align with FDA, Health Canada, and ISO standards, covering validation master plans, risk assessments, and data integrity. We support change control, CAPA execution, and audit responses, ensuring systems meet regulatory requirements for pharmaceutical, food, and medical device industries.
Facility Expansion
We design and validate greenfield facilities, refurbishments, and process improvements for regulated sectors. Our expertise includes spatial analysis, utility integration, and GMP-compliant layouts, ensuring seamless expansion while meeting operational and regulatory demands for pharmaceutical and nutraceutical manufacturing.
Automation
Automation solutions for pharmaceutical and radiopharmaceutical processes, including machine vision and visual inspection systems. We deliver FAT/SAT, commissioning, and qualification services to enhance efficiency, accuracy, and compliance in manufacturing environments.
People
Mark
Founder & Technical Leader
With 41 years of experience in regulated industries, Mark founded SAGE in 2000. He provides technical leadership in engineering design, project management, and quality assurance, ensuring client projects meet rigorous industry standards through integrity and innovation.
Ryan
Business Development Lead
Ryan oversees client services with 15 years in pharmaceutical manufacturing. His expertise includes parenteral drug inspection, automation, and process design, leveraging global top-10 pharma experience to deliver tailored solutions that enhance operational efficiency and compliance.
Golbahar
Professional Engineer
Golbahar specializes in radiopharmaceutical facility engineering and validation, with 15 years in FDA/HC-regulated industries. She combines manufacturing and LEAN methodologies to achieve project goals in sterile production, equipment validation, and compliance within tight timelines and budgets.
Questions
What industries does SAGE Engineering Services specialize in?
We specialize in pharmaceuticals, medical devices, nutraceuticals, and radiopharmaceuticals, providing engineering, compliance, and validation services tailored to regulated manufacturing environments.
How does SAGE approach client collaboration?
We integrate with client teams to deliver customized solutions, emphasizing teamwork, quality, and commitment. Our professionals work alongside clients to ensure projects meet regulatory and operational goals.
What sets SAGE apart in regulated engineering?
With over 25 years of experience and strategic partnerships, we offer deep expertise in radiopharmaceuticals, automation, and compliance. Our team’s hands-on industry background ensures practical, fit-for-purpose solutions.
Do you provide international project support?
Yes, we serve clients across North America and globally, delivering cost-effective engineering and validation services that meet international regulatory standards.
How does SAGE ensure regulatory compliance?
Our consultants stay updated on FDA, Health Canada, and ISO regulations, offering validation master plans, risk assessments, and audit support to ensure systems meet evolving compliance requirements.
