Counterfeit analysis for pharmaceuticals & medical devices

Protect patients, products and your reputation with our expert counterfeit pharmaceuticals and medical device analysis


RSSL helps pharmaceutical and medical device companies rapidly authenticate suspect products, packaging and components safeguarding supply chains and supporting regulatory investigations.

 

Counterfeit medicines and device components present a critical risk to patient safety, regulatory compliance and brand trust. Whether you’re facing a suspected falsified drug product, unauthorised distribution, tampered packaging or unexplained performance failures, RSSL provides fast, reliable counterfeit analysis to confirm authenticity and give you clear evidence for corrective action.

 

 

What we can do to support your investigation:
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Counterfeit investigations can arise at various points within the supply chain from multiple sources such as suspected falsified products, complaints and product quality concerns through to the authentication of returned, diverted or parallel goods. RSSL provides rapid, expert support to help maintain compliance and safeguard reputation whether that’s when packaging or component integrity is questioned or when data is needed to verify the legitimacy of a supplier or distributor. 

 

 

We combine advanced analytical science with deep regulatory knowledge to give you rapid clarity and confidence during counterfeit investigations. Our experts deliver fast confirmation of authenticity or falsification, supported by root-cause understanding.

 

From identifying alternative ingredients, impurities and undeclared materials to uncovering physical or compositional differences. We provide clear, defensible evidence suitable for MHRA, FDA and internal investigations, backed by a robust GMP compliant quality system. 

 

To ensure the strongest scientific outcome, we select techniques according to the evidence required for each case. Typical methods can include:

 

 

 

Specialist tools

 

We also apply a range of specialist investigative tools where appropriate, including:

 

 

  • Colourimetry and digital imaging to quantify colour differences, detect subtle packaging or label variations, assess coating uniformity, and identify visually imperceptible inconsistencies indicative of counterfeit production.

 

  • X-ray Diffraction (XRD) for identifying crystalline structures, polymorphs, and material phases, critical for active pharmaceutical ingredients and medical device components.

 

 

  • Dissolution Testing for evaluating the release characteristics of active pharmaceutical ingredients from dosage forms, a key indicator of drug performance and quality.

 

 

  • Mechanical, thermal, particulate and impurity analysis, all tailored to provide you with the specific evidence your investigation requires

 

 

We are an independent, trusted laboratory partner to major global pharmaceutical and medical device businesses. Positioned to be agile, RSSL provides fast mobilisation for urgent cases with specialist teams in both analytical and medical device performance testing to ensure you have the right expert looking at your investigation.  

 

Counterfeit investigation workflow

 

1. Case initiation

 

Suspected falsified product

Complaint / quality concern

Questioned packaging or component integrity

Returned / diverted / parallel stock

 

 

2. Triage & scope definition

 

Risk assessment
Review of reference materials / exemplars
Define required evidence (chemical, physical, etc.)
Select priority techniques

 

 

3. Analytical planning

 

Tailor method panel to the case requirements
Determine destructive vs non-destructive testing
Prepare chain-of-custody

 

 

4. Core analytical testing

 

Chemical Analysis: LC‑MS, GC‑MS, NMR
Spectroscopy & Material Analysis: FT‑IR, Raman, Microscopy
Physical & Visual Examination: Micro‑CT, Colourimetry
Mechanical, thermal & particulate testing

 

 

5. Comparative assessment

 

Match vs authentic reference
Assess chemical, structural & visual deviations
Determine conformity or falsification likelihood

 

 

6. Root cause investigation

 

Match vs authentic reference
Assess chemical, structural & visual deviations
Determine conformity or falsification likelihood

 

 

7. Reporting & evidence

 

Clear, defensible findings
Evidence suitable for MHRA / FDA / internal use
Recommendations for corrective action

 

 

8. Ongoing support & consultancy

 

Supplier verification
Packaging design improvements
Repeat monitoring or extended analysis

 

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