Pharmaceuticals

Companies within this industry can use these claims to help develop and test new
products, materials, and technologies.

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Research & development

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Pharmaceuticals

What Qualifies as R&D
in the Pharmaceutical
Industry?

Pharmaceutical companies are likely to have R&D as their core purpose and tend to have multiple qualifying projects. Qualifying R&D expenditure is often found in the development of new or alternative materials, product development including trials or prototypes through to full scale production batches and the development of new or improved diagnostical tools with better sensitivity, range, or accuracy.
Often, companies in this sector need to innovate in response to changes in health, safety, and environmental legislation.

16K+

Over 16,000 Claims

£1.77Bn+

£1,775,000,000 Reclaimed

£110K+

Average Claim Value Is Over £110,000

Examples of Qualifying R&D Activity in
the Pharmaceutical Industry

Developing or adapting a manufacturing process for a new drug.

Pre-clinical trials which are concerned with the non-human testing of compounds. Compounds that are identified as promising at the pre-clinical trial stage move into clinical trials.

Clinical trials go through three phases, they could generally be described as toxicity tests (phase 1), preliminary efficacy tests (phase 2) and comparative efficacy and tolerability tests (phase 3). Work in these first 3 stages will likely be considered R&D. This will likely include work on applying to and responding to the regulator, and work on doing further testing as requested by the regulator.

Most of the work involved in making an application to the regulator would involve work that directly contributes to the resolution of technological uncertainty and would therefore qualify as R&D.

Exploring new testing techniques and methodologies
(including testing challenges).

Improving existing testing process.

Packaging development, including challenges around packaging (combating counterfeit drugs, unit-dose control, child resistant packaging, eco-friendly and sustainable packaging).

Sustainability (using sustainable materials, using recyclable materials, developing reusable packaging, reducing the amount of material used, reducing waste from damage and contamination).

Security and anti-counterfeiting.

Temperature-sensitive pharmaceuticals.

Post-launch phase – occurs when a product has been licensed. Thus, this phase involves post-marketing confirmatory studies, special interest studies, longer-term efficacy, tolerability etc. Work in this phase would generally not be considered R&D unless the work involved a scientific or technologically advanced
uncertainty.

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