Who We Are

A laboratory designed for clients who answer to a regulator.

Lunar Labs Ltd is a UK contract testing laboratory based in Park Royal, London. We provide analytical, microbiological, regulatory and consultancy services to pharmaceutical, nutraceutical, food and veterinary clients across the UK and EU.

We work with manufacturers, sponsors, CDMOs and brand owners — anyone who needs independent, regulator-grade evidence about the identity, quality, safety or stability of their product.

Designed to MHRA and EU GMP standards
ICH-aligned method development and validation
Reports written to drop into regulatory dossiers

Regulatory Status

Where We Are on Authorisation

We believe in being transparent about regulatory status — not least because our clients are too.

MHRA Application

Application submitted and currently under review. We do not yet hold an MHRA Manufacturer's Specials Licence or Manufacturer's Authorisation. As soon as authorisation is granted we will publish the licence number, scope and inspection date on this page.

EU GMP Alignment

Our quality system, methods, equipment qualification and documentation are designed against EudraLex Volume 4 — Parts I and II — and the relevant Annexes (1, 11, 15, 19).

ICH Method Standards

Method development, validation, transfer and verification are designed against ICH Q2(R2). Stability against ICH Q1A(R2) and Q1B. Specifications against ICH Q6A. Risk against Q9.

Compendial Methods

Where a USP, Ph. Eur. or BP monograph applies, we use it. Where no monograph exists, we develop a fit-for-purpose method validated to ICH Q2 acceptance criteria.

How We Work

Four Steps from Brief to Report

1

Brief & Scope

Send us a one-paragraph description. We come back within a working day with a proposed scope, methods and timeline.

2

Method & Protocol

We confirm the method (compendial or developed) and the test plan. You receive a signed protocol before any sample arrives.

3

Laboratory Work

Sample receipt, chain of custody, analysis and review by Quality. Pull-points and stability events tracked actively.

4

Report & Support

Dossier-ready report. We support you through any regulator follow-up questions and any change-control work that flows from the result.

About Lunar Labs