Quality systems that hold up under any inspection.
Quality & Compliance Services
A pharmaceutical quality system is what stands between a good process and a reliable product. PharmExpert designs, builds and strengthens quality systems aligned to ICH Q10 that are practical to operate and robust under inspection — and provides the specialist services modern GMP demands, from qualification and validation to contamination control and toxicological limits.
From end-to-end QMS implementation and competency-based training to QP services, Contamination Control Strategy, quality metrics and PDE/ADE & OEL/OEB derivation, we help you embed quality that scales with your organization and satisfies global regulators.
Standards & Frameworks
- ICH Q10
- EU GMP Chapter 1 & 4
- 21 CFR 211
- ICH Q9
- ISO 9001
- EU GMP Chapter 2
- 21 CFR 211 personnel
- WHO GMP training expectations
- EU GMP Annex 15
- ICH Q8(R2)/Q9/Q10/Q11/Q12
- FDA Process Validation Guidance
- EMA HBEL guideline
Talk to a quality & compliance services specialist
Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.