By Phase

Preclinical Phase Testing

Analytical support that bridges discovery into regulated development — formulation characterisation, dose verification, impurity profiling and supportive method development ahead of GLP toxicology, IND and CTA submissions.

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What It Covers

Scope of Work

Dose-formulation analysis (homogeneity, concentration, stability) for tox studies

Impurity profiling for tox-batch material

Stability-indicating method development for IMP candidates

Reference-standard characterisation and qualification

Stress and forced-degradation studies for IND-enabling work

Container compatibility for dosing vehicles

Bioanalytical liaison and matrix-effect screening

Specifications drafting against ICH Q6A principles

How We Do It

Methods & Instrumentation

HPLC / UPLC

Stability-indicating assay and related substances for IMP.

LC-MS / LC-MS/MS

Impurity quantification and metabolite scouting.

GC / Headspace

Residual solvents per ICH Q3C in tox-batch material.

Dissolution

Early-formulation dissolution screening.

Karl Fischer

Water content for moisture-sensitive APIs and excipients.

Forced Degradation

Acid, base, oxidation, heat, light per ICH Q1A / Q1B principles.

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.

ICH Q2(R2) — Method Validation

ICH Q3A — Impurities in New Drug Substances

ICH Q3B — Impurities in New Drug Products

ICH Q6A — Specifications

IND / CTA expectations (FDA / MHRA / EMA)

GLP framework for tox-supportive analytics

What You Receive

Typical Deliverables

Dose-formulation analysis report per study day

Reference-standard characterisation report

Validated / qualified method ready for clinical use

Impurity-profile report with proposed specifications

Stability data package supporting IND / CTA

Tox-batch CoA with full data tables

Who It's For

Sectors We Support

Sponsors preparing IND / CTA submissions

Biotechs progressing candidates into GLP toxicology

CROs running preclinical programmes

CDMOs producing tox-batch material

Academic translational programmes

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