Supporting Life Science Startups with Scalable Quality Systems
Launching a new drug or medical device is complex, and early-stage companies must balance innovation with regulatory compliance. At UQMC, we help startups and biotech organisations build flexible, phase-appropriate Quality Management Systems (QMS) that evolve with their development journey. Our approach ensures compliance without unnecessary complexity, so you can focus on growth, investment readiness, and successful product development.
Tailored Quality Systems for Every Stage of Development
We design and implement QMS procedures aligned with your current phase of drug or device development, ensuring regulatory compliance while keeping project management efficient. Whether you’re in preclinical research or preparing for clinical trials, our solutions scale as you progress.
Audit Support & Risk Mitigation
Compliance issues can derail timelines and investor confidence. We provide comprehensive audit support, assessing internal systems, service providers, and outsourcing partners to identify and resolve gaps before they become problems.
Documentation Review & QA Oversight
Regulatory success depends on precision. We review critical documents, including Quality Agreements, Batch Manufacturing Records, and other essential documentation, to ensure compliance, accuracy, and audit readiness.
Quality Systems Due Diligence
Considering an acquisition, investment, or new outsourcing partner? Our Quality Systems Due Diligence services help you evaluate potential risks, assess system quality, and make informed decisions that protect your organisation’s future.
By partnering with UQMC, startups and early-stage organisations gain the confidence to navigate regulatory challenges, reduce risk, and build a foundation for long-term success.
Strengthening Compliance & Efficiency for Manufacturers & Service Providers
In highly regulated industries, a well-structured Quality Management System (QMS) is essential for compliance, efficiency, and long-term success. At UQMC, we help manufacturers and service providers refine their QMS, training programs, and digital transformation strategies to ensure seamless operations and audit readiness.
Customised Quality Systems Assessment
No two organisations are the same. Our Customise-Simplify framework allows us to conduct tailored QMS assessments that align with your unique operational needs. We identify compliance gaps, inefficiencies, and opportunities for improvement—providing actionable recommendations that enhance both regulatory adherence and business performance.
Tailored Training & Coaching
A well-trained team is your greatest asset in maintaining compliance. We provide custom QMS and GMP training designed to equip employees with the knowledge and skills needed to uphold quality standards. Visit our Training section to explore our interactive coaching approach.
Digital Transformation Support
Modern QMS solutions require strategic digital integration. We help businesses develop, plan, and implement digital transformation initiatives that streamline compliance processes. Our services include training, implementation support, and post-integration effectiveness reviews, ensuring a smooth transition and maximum impact.
Quality Culture Assessment and Improvement
Compliance is more than policies and procedures—it’s about mindset and culture. We evaluate your current quality culture, pinpoint areas for growth, and develop custom improvement plans focused on sustained compliance and continuous improvement.