Regulatory Intelligence

Research ethics approval, IRAS applications, informed consent requirements, transparency obligations and REC guidance for UK trials.

E6(R3) GCP, E8 study design, E9(R1) statistical principles, E17 multi-regional trials, E19 safety data. The foundational standards for global trial conduct.

UK clinical research funding, infrastructure guidance, decentralised trial frameworks, and research delivery standards across the NHS.

UK marketing authorisation, pharmacovigilance (Yellow Card), clinical trial authorisations, device regulation post-Brexit, and UKCA marking.

EU centralised procedure, CHMP scientific opinions, orphan designation, PRIME scheme for breakthrough therapies, scientific guidelines and reflection papers.

US IND, NDA, ANDA submissions, breakthrough therapy designation, accelerated approval pathways, REMS programmes and post-market surveillance.

Biologics license applications (BLA), vaccines, cell and gene therapy (RMAT), blood products, tissue-engineered products and regenerative medicine.

SDTM, ADaM, CDASH and ODM data standards. Required for all FDA electronic submissions since 2017 and increasingly expected by EMA. Critical for biometrics teams.

All FDA guidance across drugs, biologics, devices and combination products. Covers statistical methodology, adaptive designs, real-world evidence, and digital health.

510(k), PMA and De Novo pathways, combination products, Software as a Medical Device (SaMD), digital health tools and in vitro diagnostics.

NICE TA decisions determining NHS reimbursement. If NICE recommends, the NHS must fund within 90 days. The single most important market access signal for England.

Clinical guidelines, quality standards, EAMS (Early Access to Medicines), Highly Specialised Technologies (HST) and the Innovative Medicines Fund.

NHS commissioning policy, formulary decisions, Cancer Drugs Fund, commercial access agreements, and NHS England medicines optimisation guidance.

HTA licensing for organisations storing or using human tissue, biobanking standards, consent requirements under the Human Tissue Act 2004, and import/export of samples.

Research ethics framework for tissue banks and biobanks, generic ethics approval for sample collections, and governance for sample-based research in the UK.

UK pharma industry positions, ABPI Code of Practice, policy responses to MHRA/NICE consultations, and guidance on industry-NHS collaborations and patient engagement.

Good Automated Manufacturing Practice — the industry standard for computer systems validation (CSV). GAMP 5 Second Edition (2022) is the accepted framework for MHRA and FDA computerised systems audits.

Post-market safety signals, drug recalls, REMS updates, and MedWatch safety communications. Key for pharmacovigilance teams and safety reporting obligations.