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Pharmaceutical QMS Design & Rollout Support

We move beyond templated solutions. Our approach is to understand your product, your process, and your people to create a QMS that is: Proactive & Risk-Based: Integrated with ICH Q9 (Quality Risk Management) principles. Lean & Scalable: Designed for your current phase (clinical to commercial) and future growth. People-Centric: Fostering a sustainable culture of quality and continuous improvement.

1. Strategic QMS Design & Gap Analysis

  • Current State Assessment: Comprehensive evaluation of existing processes against ICH Q10, EU GMP, 21 CFR 210/211, and Annex 1 requirements.

  • Strategic QMS Roadmap: Develop a phased, prioritized implementation plan aligned with product development timelines and regulatory milestones (e.g., pre-approval inspection readiness).

  • Quality Policy & Manual Development: Crafting the foundational documents that define your quality objectives and management commitment.

2. Procedural Framework Development

We design and author the complete suite of controlled documents:

  • Level 1 (Policies): High-level commitment documents (e.g., Data Integrity Policy, Supplier Management Policy).

  • Level 2 (Processes/SOPs): Core operational SOPs (Change Control, Deviations/CAPA, Management Review, Training, Document Control, Internal Audit, Complaints, Recall).

  • Level 3 (Work Instructions & Forms): Practical, user-friendly instructions and templates to ensure consistent execution.

  • Technology Integration: Guidance on selecting and implementing QMS software (e.g., Veeva, TrackWise, MasterControl) and ensuring electronic records compliance (21 CFR Part 11, EU Annex 11).

3. End-to-End Rollout & Implementation Support

  • Project Management: Dedicated support to manage the rollout timeline, resources, and deliverables.

  • Stakeholder Engagement & Communication: Developing change management plans to secure buy-in from R&D, Manufacturing, and QC/QA teams.

  • Training Program Development & Delivery: Creating role-based training curricula and materials to ensure effective competency building. We "train the trainers" for sustainability.

  • Pilot Phase Facilitation: Guiding a soft launch in a selected department to refine processes before full-scale deployment.

4. QMS Health Check & Optimization

  • Post-Implementation Audits: Assessing the effectiveness and adherence to the new system.

  • Performance Metrics (KPIs) Design: Establishing meaningful metrics to monitor QMS health (e.g., CAPA cycle time, training compliance, deviation trends).

  • Continuous Improvement Integration: Setting up Management Review processes to drive data-driven decisions and perpetual improvement.

Key Differentiators for Our Pharmaceutical Consultancy

  • Regulatory-Strategic Alignment: Our consultants are former industry leaders and experienced auditors. We ensure your QMS not only passes inspections but also adds tangible business value.

  • Phase-Appropriate Approach: Tailored systems for Clinical Trial Material (IMP) manufacturing vs. commercial production.

  • Specialized Expertise: Deep dives into critical, high-risk areas:

    • Data Integrity by Design: Building ALCOA+ principles into procedures and systems from the start.

    • ATMPs & Advanced Therapies: QMS considerations for cell and gene therapies.

    • C(G)MP for API: QMS design for Active Pharmaceutical Ingredient manufacturing (ICH Q7).

  • Hands-On Partnership: We work alongside your team to transfer knowledge, not just deliver a report.

Ideal For

  • Emerging Biotechs: Building your first GMP-ready QMS for Phase I/II trials.

  • Established Pharma: Modernizing a legacy QMS, post-merger integration, or preparing for PAI (Pre-Approval Inspection).

  • Virtual Companies: Establishing a complete, vendor-managing QMS for outsourced operations.

  • CDMOs: Enhancing client confidence through a demonstrably robust QMS.

Let us help you transform quality from a compliance obligation into your most significant competitive advantage.

Contact us today for a confidential discussion about your QMS challenges and objectives.