Validica: Smart Compliance

Validica is a consultancy firm specializing in the pharmaceutical industry, Quality Management Systems, and Regulatory Compliance. We help companies translate regulatory requirements into practical, effective solutions.

At Validica, we believe GMP is not one-size-fits-all. We apply our regulatory knowledge, technical understanding, and inspection experience to design tailored approaches for each product, process, and facility that meets regulatory expectations. We work with a phase-appropriate GMP mindset that aligns systems with the development stage of your drug product - ensuring risk-based, scientifically justified compliance.

This is Smart Compliance: a way of working where regulatory rigor meets innovative thinking.

What We Do

Our Services

Inspection Readiness

Mock inspections, readiness plans, and EU/FDA inspection remediation

GMP Quality Oversight

Quality system design, gap assessment, and continuous improvement

Validation Documentation

Cleaning, process, and analytical validation strategies and protocols

Regulatory Support

CMC documentation and DMF/IND/NDA/ANDA/IMPD submissions (eCTD-ready)

About

Laura Moreno

Pharma Quality & Regulatory Consultant | GMP Compliance | EU QP

I am a GMP compliance expert with a dedicated career to the pharmaceutical industry, specializing in GMP Quality and Regulatory requirements and certified EU Qualified Person (QP) under Directive 2001/83/EC.

Having leading Quality Systems across the full product lifecycle — from API and Drug Product manufacturing to aseptic operations, inspection readiness, and commercial release, I support GMP certifications from scratch, FDA/EMA inspection readiness programs within CDMO environments, remediation and Warning Letter support.

My technical focus includes process validation (PPQ), cleaning and analytical validation, batch certification, and risk-based quality management. I work with a practical and science-driven approach.

My background includes a PhD in Medicinal Chemistry and a career path from Quality Control Specialist, QA Director and Qualified Person and Senior Consultant. I believe strong quality comes from understanding the rules and applying them with judgment.

I founded Validica to deliver smart, tailored GMP compliance — combining technical rigor with pragmatic solutions that support innovation.

15+ Years of Experience

EU QP Qualified Person

PhD Medicinal Chemistry

MSc Regulatory Affairs