qualprep.com

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 & EMA visits are a showcase, not a scramble.

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.

Capabilities
QualPrep supports organizations across the full lifecycle of regulated system readiness — from AI/ML governance to validation, Quality oversight, and enterprise enablement. Our capabilities help technical and Quality teams navigate compliance with confidence and speed.
AI/ML & Quality Governance
Frameworks for responsible development and deployment, aligned to health authority expectations and enterprise Quality Systems.
Validation & Documentation
Computer System Validation (CSV/CSA), AI/ML validation, protocol development, evidence packages, and lifecycle documentation.
Data Integrity & Technical Controls
Risk-based DI assessments, ALCOA+ implementation, system hardening, and remediation planning.
Internal Audits & Readiness
Internal audits, health authority readiness, mock inspections, and CAPA systems oversight.
Remediation & Quality Systems
Program-level remediation, process redesign, documentation cleanup, and QA function uplift.
Corporate Training & Enablement
Training for technical, Quality, and leadership teams on AI/ML governance, validation, inspection readiness, and modern GMP practices.
QualPrep — Advisory Services
Expert support across regulated systems, validation, AI/ML governance, GMP expectations, data integrity, internal audits, remediation, inspection readiness, and enterprise enablement. All engagements begin with a formal Statement of Work (SOW) and are invoiced through QualPrep.
Consultation (Full Day)
$3,900
Minimum engagement for new clients
One full day of dedicated advisory covering strategy, validation planning, readiness evaluations, or regulatory guidance for technical and Quality teams.
Project Work
$325 / hour
Applied to validation activities, documentation design, remediation work, governance frameworks, regulated AI/ML support, and internal audits.
Corporate Training
Starting at $6,500
Onsite and virtual training programs covering AI/ML governance, GMP expectations, validation fundamentals, inspection readiness, and Quality culture enablement. Pricing varies based on duration, audience size, and customization level.
To begin an engagement or request a Statement of Work, please contact us .
QualPrep

© 2025 QualPrep. All rights reserved.

Informational use only. Services are provided solely under a written engagement.

Privacy & cookies: we use only essential cookies and basic analytics. Personal data is limited to what you submit (e.g., forms) and retained only as needed to deliver services. We do not sell your data. To request access, correction, or deletion, email [email protected].

All trademarks and product names are the property of their respective owners.

// Auto-update year (function () { var el = document.getElementById('year'); if (el) el.textContent = new Date().getFullYear(); })();

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

Ready to elevate your quality assurance?

Partner with QualPrep to strengthen your compliance frameworks, prepare with confidence, and deliver lasting quality results.

QualPrep

© 2025 QualPrep. All rights reserved.

Informational use only — nothing here is regulatory, legal, medical, or investment advice. Services are provided solely under a written engagement.

Privacy & cookies: we use only essential cookies and basic analytics. Personal data is limited to what you submit (e.g., forms) and retained only as needed to deliver services. We do not sell your data. To request access, correction, or deletion, email [email protected].

All trademarks and product names are the property of their respective owners.

// Auto-update year (function () { var el = document.getElementById('year'); if (el) el.textContent = new Date().getFullYear(); })();

Thank you

Your message is received, we will get back to you soon.