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.
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 & 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.
Empowering Teams Through Training & Workforce Development
A strong Quality Management System (QMS) is only as effective as the people who run it. At UQMC, we believe that training is not just about compliance—it’s about building a knowledgeable, confident, and quality-driven workforce. Our training programs are designed to equip teams with the practical skills and regulatory expertise needed to maintain compliance, improve efficiency, and drive continuous improvement.
Customised QMS & GMP Training
Regulations evolve, and so should your team. We offer tailored training programs on QMS, GMP, and industry best practices, ensuring employees stay up to date with the latest compliance requirements. Each program is designed to be practical, engaging, and aligned with your organisation’s specific needs.
Audit Support & Risk Mitigation
Sometimes, standard training isn’t enough. Our one-on-one coaching sessions provide personalised guidance to help employees apply compliance principles effectively in real-world scenarios. Whether your team needs audit preparation, leadership mentoring, or hands-on compliance support, we tailor coaching to maximise impact.
Immersive Training with VR & AR
Learning should be interactive and engaging. We incorporate Virtual Reality (VR) and Augmented Reality (AR) into our training programs, allowing employees to experience realistic, scenario-based learning. This hands-on approach helps teams retain knowledge, improve decision-making, and confidently apply compliance principles in their daily work.
Compliance Workshops & Group Training
For teams that learn best through collaboration, we offer customised workshops and group training sessions. These interactive programs cover QMS, GMP, risk management, and audit preparedness, fostering teamwork and shared accountability. Our workshops combine real-world case studies, scenario-based learning, and hands-on exercises, ensuring your team gains practical skills that drive long-term compliance and operational excellence.
Ready to Strengthen Your Quality Systems and Stay Ahead of Compliance?
At Urmi Quality Management Consulting, we don’t just help you tick boxes—we partner with you to build smarter, stronger, and more efficient quality systems. Whether you’re a startup navigating clinical development, a CDMO managing complex operations, or a manufacturer striving for continuous improvement, our tailored QMS solutions are designed to keep you compliant, audit-ready, and operationally excellent.
With over 25 years of experience in pharmaceutical and life science quality systems, we understand the pressures of regulatory compliance—and how to turn them into your competitive advantage.
Let’s simplify compliance and elevate performance—together.
Get in touch today to book a consultation or explore how we can support your next stage of growth.