Specialist Investigations

Problem Solving & Contamination Investigation

Root-cause investigation for unknown peaks, contamination events, OOS results, particulate matter and supply-chain anomalies. When the analytical answer is "we don't know yet" — we go and find out.

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What It Covers

Scope of Work

Unknown-peak identification in HPLC / GC chromatograms

Particulate matter analysis and foreign-body identification

OOS / OOT investigation with documented root cause

Supply-chain anomaly investigation (raw material, supplier change)

Process-derived contamination tracing

Cleaning failure investigation and remediation support

Adulteration and economic-fraud screening

Off-odour, off-flavour and customer complaint investigation

How We Do It

Methods & Instrumentation

LC-MS / LC-MS/MS

Trace impurity and unknown-peak structural elucidation.

GC-MS / Headspace

Volatile profile and contaminant ID for off-odour / off-flavour investigation.

ICP-MS

Elemental and trace-metal contaminant identification.

FTIR / Microscopy

Particulate matter identification and material-class assignment.

HPLC / UPLC

Quantitative contaminant tracking once identified.

NMR (on referral)

Structural confirmation for novel unknowns.

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 OOS / OOT investigation expectations

MHRA / FDA OOS guidance

ICH Q9 — Quality Risk Management

USP <788> — Particulate Matter (where applicable)

ISO 17025-style traceability for raw data

What You Receive

Typical Deliverables

Investigation protocol and execution report

Root-cause analysis with documented evidence trail

Structural proposal for unknown peaks / particulates

Remediation recommendation with verification criteria

Supplier / process change-control supportive analytics

Customer-facing complaint resolution memo

Who It's For

Sectors We Support

Pharmaceutical and consumer healthcare manufacturers

Nutraceutical and food brands with complaint events

CDMOs needing rapid investigation capacity

Quality teams managing regulator queries

Insurers and lawyers in product-liability investigations

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