Typical Areas of R&D Activity

• Drug discovery and pre-clinical research, target validation, lead optimisation and ADME profiling.
• Process development and scale-up, upstream and downstream optimisation, impurity control and CMC work.
• Diagnostics and devices, assay sensitivity and specificity, biomarker validation, device design and firmware.
• Clinical data and bioinformatics, study design support, analytics pipelines and real-world evidence.
• Digital health, software as a medical device, interoperability, data security and patient safety features.
• Quality and compliance innovation, validation methods, automated testing and risk controls.

Common Challenges

The boundary between regulatory work and qualifying R&D can be difficult to evidence. Data integrity, confidentiality and third-party collaboration also complicate documentation and cost capture.

• Defining uncertainty, beyond routine validation and compliance activity.
• Attribution, allocating costs across internal teams, CROs, EPWs and partners.
• Data sensitivity, creating narratives that inform HMRC without disclosing restricted details.

How We Support You

• Partner-led discovery with science leads and regulatory teams to isolate qualifying work.
• Robust narratives aligned to HMRC’s expectations and current DSIT guidance.
• Subcontracting and territorial compliance review under the Merged RDEC scheme.
• Comprehensive enquiry defence included as standard.
• Portfolio planning across multi-year programmes to improve claim efficiency and evidence quality.