Quality Management System (QMS) Design & Support

What We Offer

We help you build QMS frameworks that are:

• Fully aligned with UK GDP Guidelines and MHRA expectations

• Clear and easy to use across departments and roles

• Scalable for new licences, additional sites, or growth

• Practical and operational—not just theoretical

• Designed for continuous improvement and regulatory resilience

• Designed specifically to meet your business needs

Whether you're starting from scratch or need to enhance your current system, our QMS support ensures you have a functional, compliant, and auditable system that reflects how your business operates.

What’s Included in Our QMS Management & Support Service?

We don’t just help you design a Quality Management System—we work with you to ensure it remains functional, compliant, and audit-ready every day. Here's how our expert support helps protect your licence and streamline your operations:

• Assistance with QMS implementation, maintenance, and regular review

We ensure your QMS is not only well-designed but actively embedded into daily operations, regularly reviewed, and updated to reflect changes in business, regulation, or risk.

• Supporting the Responsible Person (RP) in ensuring all distribution activities meet GDP standards and internal policies

We work closely with your RP, offering guidance and oversight across all GDP-governed activities to ensure every function aligns with regulatory expectations and your internal procedures.

• Maintaining accurate, GDP-compliant records of product receipt, storage, and distribution

We help implement robust systems for record-keeping—ensuring full traceability and documentation that stand up to MHRA inspection.

• Managing and coordinating deviations, complaints, CAPAs, change controls, and quality risk assessments

We coordinate timely investigations and root cause analyses, ensuring corrective and preventive actions (CAPA) are realistic, risk-based, and regulator-aligned.

• Oversight of route risk assessments and validation for deliveries to approved customers

We support the evaluation and validation of transport routes to ensure product integrity and compliance with GDP during distribution.

• Reviewing and updating SOPs, forms, and associated documentation to ensure GDP compliance

We ensure your documentation reflects your operations accurately, minimising audit findings and ensuring staff clarity on responsibilities.

• Participation in internal audits, supplier audits, and self-inspections with full documentation and follow-up

We help you identify risks proactively and take corrective action before they become regulatory issues—strengthening inspection readiness.

• Supporting transport and storage provider qualification and ongoing performance monitoring

We assist with qualifying third parties and monitoring them regularly to ensure compliance across your extended supply chain.

• Ensuring temperature monitoring and environmental controls are effective, with proper deviation handling

We ensure your storage and distribution environments are monitored and deviations are managed promptly to maintain product quality.

• Assisting in regulatory inspection preparation, participation, and response

We help you prepare for MHRA inspections, act as your compliance partner during audits, and support with post-inspection remediation if needed.

• Contributing to GDP training, including onboarding and refresher training aligned with your QMS

We help train your staff on SOPs, compliance expectations, and GDP responsibilities to build a culture of quality and awareness.

• Taking part in quality reviews and leadership meetings, providing updates on GDP metrics and issues

We provide meaningful insight to leadership, enabling smarter decisions based on real-time quality data and trends.

• Coordinating GDP documentation and controlled records to support traceability, compliance, and continuous improvement

We help you maintain clean, well-organised documentation that supports audits, traceability, and regulatory reporting.

Who is our QMS support ideal for

• New WDA applicants building a system from the ground up

• Existing licence holders upgrading or restructuring operations

• Companies who have received MHRA inspection findings

• Businesses with complex contractor or logistics setups

• Any organisation undergoing growth or operational change