By Phase

Manufacturing & Commercialisation

Routine release testing, ongoing stability, change-control support and post-marketing surveillance analytics for commercial pharmaceutical, consumer healthcare and veterinary products. The work that keeps inspection-ready supply moving.

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What It Covers

Scope of Work

Routine batch release testing against commercial specification

Annual stability commitments per ICH Q1A

Variations support — analytical evidence for Type IA / IB / II

Change-control supportive analytics (process, supplier, site)

Cleaning verification and shared-line risk monitoring

OOS / OOT investigation with documented root cause

Post-marketing surveillance and complaint sample analysis

Annual Product Quality Review (PQR) supportive analytics

How We Do It

Methods & Instrumentation

HPLC / UPLC

Routine assay, related substances, content uniformity.

LC-MS / LC-MS/MS

Trace-level impurity quantification and complaint-sample investigation.

GC / Headspace

Residual solvents per ICH Q3C and USP <467>.

ICP-MS

Elemental impurities to ICH Q3D for commercial supply.

Dissolution

USP Apparatus 1, 2 with auto-sampling and bracketing.

Microbial Limits

USP <61>, <62>, <71>, <85> per product class.

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

MHRA — UK marketed products

ICH Q1A, Q1E, Q2(R2), Q3A–D, Q6A

EU GMP Annex 19 — Reference and Retention Samples

FDA expectations for marketed-product analytics

What You Receive

Typical Deliverables

Routine release CoA per batch

Annual stability summary reports

Variations data packages (Type IA / IB / II)

OOS / OOT investigation reports with root cause

PQR supportive data tables and trend plots

Inspection-ready raw data and audit trail

Who It's For

Sectors We Support

Commercial pharmaceutical manufacturers

Consumer healthcare brand owners

Veterinary medicine manufacturers

CDMOs supplying commercial product

Generic and biosimilar manufacturers

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