Pharmaceutical Testing

Quality & Regulatory Service — MHRA & EU GMP

Quality and regulatory support designed to MHRA and EU GMP expectations. Specifications, method validation packages, stability protocols, change-control documentation, deviation handling and dossier-ready Module 3 sections for UK and EU regulatory submissions.

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What It Covers

Scope of Work

Specification design per ICH Q6A (drug substance and drug product)

Method validation packages (ICH Q2 protocol, raw data, validation report)

Stability protocol authoring (ICH Q1A) and study oversight

Module 3 (Quality) authoring and review for IMPD, CTA and MAA

Variation and renewal documentation (Type IA, IB, II)

Out-of-specification (OOS) and out-of-trend (OOT) investigations

Change-control impact assessments and supporting analytics

GMP gap-analysis and inspection-readiness support

How We Do It

Methods & Instrumentation

Specification Design

Map each attribute to a method, an acceptance criterion and a regulatory rationale.

Method Validation

Specificity, accuracy, precision, linearity, range, robustness, LOD/LOQ — full ICH Q2 package.

Stability Programme

Protocol, pull-points, storage justification, shelf-life evaluation per ICH Q1E.

Investigation Reports

Five-Whys / fishbone-driven OOS investigations with documented root cause and CAPA.

Regulatory Writing

CTD-formatted Quality sections (3.2.S, 3.2.P) with cross-references to validated methods.

Inspection Readiness

Mock audits, document-flow walkthroughs, deficiency-letter response support.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

MHRA — Human Medicines Regulations 2012

EU GMP — EudraLex Vol. 4 (Parts I, II, III, Annexes)

ICH Q1A — Stability

ICH Q2 — Validation of Analytical Procedures

ICH Q6A — Specifications

ICH Q9 — Quality Risk Management

ICH Q10 — Pharmaceutical Quality System

What You Receive

Typical Deliverables

Approved specifications with regulatory rationale

ICH Q2-compliant method validation package

Stability protocol and end-of-study report with shelf-life recommendation

CTD Module 3 sections ready for submission

OOS investigation report with documented CAPA

Inspection-ready document set, indexed and cross-referenced

Who It's For

Sectors We Support

Pharma manufacturers preparing for MHRA inspection

Generics filing UK MAA / EU MAA dossiers

Sponsors filing CTA / IMPD

CDMOs needing third-party regulatory support

Investors performing technical due-diligence

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