Browse Toolkits
Browse by lifecycle stage or search across the catalogue. Each page explains what the toolkit does, who it is for, and the Word and Excel files it includes.
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Stage 0 through Stage 9
Each stage opens its own focused catalogue, so you never have to work through one enormous page of unrelated toolkits.
Cross-functional governance and quality systems used across the full drug-development lifecycle.
Document control, accountability, training, vendor oversight, quality risk, data integrity, and programme governance.
Tools for defining the target product, selecting candidates and connecting scientific evidence to development decisions.
Target product strategy, candidate selection, translational planning, ADME/DMPK, and pharmacology governance.
Operational documentation for planning, overseeing and evidencing the nonclinical package that supports clinical entry.
Nonclinical strategy, GLP oversight, toxicology, safety pharmacology, bioanalysis, SEND readiness, and first-in-human decisions.
Controls for developing, manufacturing, testing, releasing and maintaining investigational products.
CMC strategy, drug substance and product development, analytical methods, release, stability, comparability, and CMO oversight.
Tools for defining regulatory pathways, preparing clinical trial applications and controlling authority commitments.
Global regulatory strategy, US IND, EU CTIS, UK CTA, investigator brochures, correspondence, commitments, and eCTD readiness.
End-to-end operational controls for designing, starting, running, closing and evidencing clinical trials.
Study governance, protocols, startup, participant protection, TMF, monitoring, vendors, safety, data, statistics, and inspection readiness.
Focused operating tools for the distinct risks and decisions within Phase I, II, III and decentralised trials.
First-in-human escalation, PK/PD operations, proof-of-concept, dose finding, pivotal readiness, and decentralised trial delivery.
Documentation for assembling, reviewing and defending the evidence required for marketing authorisation.
NDA, BLA and MAA strategy, CTD/eCTD modules, integrated summaries, benefit-risk, labelling, and pre-approval inspection readiness.
Cross-functional controls for moving an approved product into safe, compliant commercial operation.
Launch safety, medical information, product complaints, MLR review, GDP, recalls, commitments, and labelling lifecycle.
Operational systems for managing post-market safety obligations, evidence, oversight and inspection readiness.
ICSRs, literature, signals, risk management, aggregate reporting, PSMF, affiliates, vendors, training, KPIs, and document control.
Specialist add-ons
Explore documentation needs for biologics, ATMPs, oncology, paediatrics, rare disease, vaccines, and combination products.