From Chaos to Confidence in Regulatory Inspections
We help pharma and biotech companies stay inspection-ready, strengthen sterility assurance, data integrity, and simplify compliance — so FDA visits are a showcase, not a scramble.
Our Expertise
Empowering Quality Excellence
• Inspection Readiness – Mock audits, gap assessments, and preparation strategies.• Inspection Day Support– Real-time guidance and inspector communication coaching.• Sterility Assurance – Contamination control strategies that keep production safe.• Data Integrity & Validation – Practical, digital systems that connect R&D to manufacturing.• SOP Optimization – Smarter SOPs and validation docs that tell a clear, audit-ready story.
Solutions
• Inspection Readiness & Training
Mock audits, gap assessments, and team coaching refined through FDA and EMA inspections. We also guide you in real time on inspection day, ensuring clear communication and confidence with regulators.• Regulatory & Data Integrity
Frameworks aligned with FDA, EMA, MHRA, ISO 13485/14971, and 21 CFR Part 11 to ensure complete end-to-end compliance and inspection-ready records.• Quality & Compliance Programs
Reduce manual effort through structured trending, complaint analysis, and documentation practices led by proven global quality leaders.• Digital Quality Integration
Smarter SOPs, concise validation documentation, and data implementation of QMS, LIMS, and manufacturing systems.
Michael Weaver
Michael is a seasoned quality and data integrity leader with experience at top global pharmaceutical companies including Gilead, Bayer, Amgen, and Merck. He specializes in building compliance systems that integrate cutting-edge technology with regulatory requirements, helping organizations stay audit-ready while driving efficiency.
Founders
Abdel Talha
Abdel is a sterility assurance and quality expert with leadership experience as Senior Director at GSK and Vice President at Alvotech. He brings deep expertise in contamination control, sterile manufacturing, and regulatory compliance, supporting companies in delivering safe, high-quality medicines worldwide.
Why QualPrep
• Big-company experience, boutique attention• Practical, inspection-ready solutions• Software workflow best practices + consulting that sustain results
Always Inspection-Ready.
No surprises. No setbacks.
Discover the Inside Track on Global Compliance Excellence
Our latest case studies showcase how QualPrep helps clients transform compliance risks into regulatory success. From sterile vaccine manufacturing sites in the Europe to global data integrity programs and complex combination product development, these success stories highlight:• Inspection readiness: Clients passed FDA, EMA, ANVISA, and NMPA inspections without major findings.• Quality system improvements: Streamlined deviations, CAPA, and change controls across global networks.• Data integrity leadership: Building model programs rooted in ALCOA+ principles.• Risk management integration: Embedding ICH Q9 and ISO 14971 across the product lifecycle.• Harmonization success: Aligning multiple sites and supply chains under unified global quality systems.These engagements demonstrate how proactive strategy, governance, and training not only achieve immediate inspection success but also embed a lasting culture of compliance and quality excellence.
Why this matters to you:If your organization is striving to get out ahead of inspections—especially across drug, device, or combo-product lines—you’ll want to see exactly how this transformation was made possible. It’s not just about correcting gaps—it’s about embedding a culture of quality and readiness that inspectors trust.
Download the full report to see how QualPrep turns regulatory challenges into sustainable strengths.
Contact QualPrep
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Partner with QualPrep to strengthen your compliance frameworks, prepare with confidence, and deliver lasting quality results.
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