By Phase

Clinical Development Phase Testing

GMP-aligned analytical support for Phase I, II and III clinical-trial materials — IMP release, ICH-aligned stability, comparator characterisation and method validation. Built around inspection-readiness and dossier traceability.

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What It Covers

Scope of Work

IMP release testing per protocol-specified specification

ICH Q1A-aligned IMP stability with bracketing / matrixing where appropriate

Comparator characterisation and re-pack release support

Method validation / verification per ICH Q2(R2)

Method transfer between sponsor, CDMO and Lunar Labs

Forced-degradation studies to confirm stability-indicating power

Identification of unknown peaks and OOS investigation

Specifications evolution from Phase I → III

How We Do It

Methods & Instrumentation

HPLC / UPLC

Stability-indicating assay, related substances and content uniformity.

LC-MS / LC-MS/MS

Impurity ID, comparator characterisation and degradant elucidation.

GC / Headspace

Residual solvents per ICH Q3C.

ICP-MS

Elemental impurities to ICH Q3D for clinical material.

Dissolution

USP Apparatus 1, 2 with auto-sampling for clinical IMPs.

Microbial Limits

USP <61> / <62> for non-sterile clinical IMPs.

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.

EU GMP — EudraLex Vol. 4 Annex 13 (IMPs)

MHRA expectations for clinical-trial materials

ICH Q1A, Q2(R2), Q3A, Q3B, Q3C, Q3D, Q6A

FDA Phase-appropriate expectations

EU Clinical Trial Regulation 536/2014 supportive analytics

What You Receive

Typical Deliverables

IMP CoA aligned to clinical specification

IMP stability data package per ICH Q1A

Method validation / verification reports

Method transfer protocols and reports

Comparator characterisation reports

OOS / OOT investigation reports

Who It's For

Sectors We Support

Sponsors running Phase I, II or III trials

Biotech and pharma CDMOs producing IMP

CROs supporting clinical operations

Academic-investigator-led trials

Generic developers running bioequivalence studies

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