About – DP Quality Consulting

DP Quality Consulting is an independent pharmaceutical quality and regulatory consultancy. Our team has held senior quality and compliance roles inside drug manufacturing organizations, which shapes how we advise: every recommendation is weighed against what a plant can realistically execute and sustain.

We work across the categories where regulatory scrutiny is highest — sterile and non-sterile manufacturing, branded and generic products, contract and compounded operations — bringing the same rigor to a five-person compounding pharmacy as to a multinational manufacturer.

Every recommendation is grounded in current FDA cGMP requirements (21 CFR Parts 210 and 211) and ICH Q9/Q10 quality risk management principles.

Our engagement experience spans drug manufacturers and CMOs across the Americas, Europe, and Asia.

Three things that don't show up on a services page.

Practical, not theoretical

We've implemented CAPAs on real production lines, not just written them in a report. Every recommendation accounts for validation cycles, staffing, and change-control realities — not just what looks good on paper.

Both sides of the table

Our consultants have held quality and compliance leadership roles inside FDA-regulated manufacturers, and worked directly with investigators during inspections. We know what actually convinces one that a response is credible.

Defensible, on timelines you can hit

Every CAPA date, remediation milestone, and submission deadline we help you commit to is one your team can actually meet. A response that misses its own deadline does more damage than a modest one that holds.

Independent counsel, plant-floor experience.

Help drug manufacturers meet their business objectives without compromising regulatory compliance.

Three things that don't show up on a services page.

Practical, not theoretical

Both sides of the table

Defensible, on timelines you can hit