About Us
Trusted Guidance When
Compliance Matters Most
We provide senior-level quality and regulatory support to companies navigating complex FDA and global compliance requirements.
Who We Are
Built on Experience, Driven by Purpose
With decades of combined experience across pharmaceutical, biotech, OTC, dietary supplement, cosmetic, IVD, and food industries, our team brings the strategic perspective and hands-on execution needed to build compliant systems, resolve regulatory challenges, and accelerate time to market.
- We partner with early-stage to mid-size organizations.
- We specialize in building quality management systems from the ground up.
- We conduct gap assessments, prepare mock inspections, and lead remediation.
- We serve companies in pharmaceutical, biotech, OTC, dietary supplement, and cosmetic industries.
- We move quickly because we are nimble and understand the urgency of compliance timelines.
Mission
To deliver senior-level quality and regulatory leadership that helps regulated companies move forward with clarity, confidence, and compliance.
Vision
To empower life sciences organizations to achieve operational excellence, regulatory confidence, and sustainable growth through practical, high-impact quality and regulatory leadership.
Values
Integrity in every recommendation, transparency in every engagement, and an uncompromising commitment to quality and patient safety.
Our Journey
A Decade of Quality Leadership
Founded
AP Quality & Regulatory Consulting established with a focus on pharma compliance.
Expanded Services
Added FDA inspection readiness and global regulatory strategy to our offerings.
50+ Clients
Reached 50 successful engagements across pharmaceutical, biotech, and OTC sectors.
Team Growth
Expanded to a team of senior consultants with deep industry experience.
Global Reach
Supporting clients across North America, Europe, and Asia with compliance programs.
Industry Leader
Recognized as a trusted compliance partner by leading regulated industry organizations.
Leadership
Meet the Team
Andrea Paolillo
Founder & CEO
Michael Torres
Director of Regulatory Affairs
Priya Sharma
Senior Quality Consultant
David Okafor
Operations Manager
Our Environment
Where Quality Happens
Certifications & Standards
Standards We Follow and Certifications We Hold
FDA 21CFR
American Society of Quality
ICH Guidelines
RAPS
Society of Quality Assurance
Ready to Build a Compliance-First Culture?
Partner with senior-level experts who understand your regulatory challenges and deliver real results.