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Changing regulatory norms. Differing interpretations. How can your GXP-domain enterprise, dealing with patient safety, identify the right practices to implement? How can you ensure complete compliance in this environment of flux?
QMatra makes the task easy. We partner with you to develop sound quality management systems, and continuously assess and improve their performance, keeping you compliant even in a dynamic regulatory regime.
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We provide:
- Inspection support. Understand key criteria for regulatory reviews, prepare for relevant procedures and stay inspection-ready.
- Due diligence. Evaluate capabilities of potential vendors and partners before collaboration. Determine the best fit with your operating environment and plan for strategic growth.
- QMS review and gap analysis. Align your organisation’s current quality management systems with regulatory expectations. We help determine the gaps and support you in bridging them.
- Risk assessments. Identify and address risks proactively – at strategic, programme and operational levels.
- SOP development and review. Define high-efficiency processes for specific studies or key operational procedures. Bridge the gap between strategy and implementation as we hand-hold you through the transition.
