2.1
86
Nonclinical Development Plan & IND/CTA-Enabling Strategy
Define the nonclinical package needed to support IND, CTA, first-in-human, and clinical development.
View toolkitStage 2
GLP and IND/CTA-enabling nonclinical development
Operational documentation for planning, overseeing and evidencing the nonclinical package that supports clinical entry.
What this stage covers
Nonclinical strategy, GLP oversight, toxicology, safety pharmacology, bioanalysis, SEND readiness, and first-in-human decisions.
How it helps your team: Surface evidence gaps and dependencies before they delay IND, CTA, or first-in-human decisions.
12 toolkits
Choose the operational area you need
2.2
76
GLP Compliance & Sponsor Oversight
Ensure GLP studies are appropriately planned, overseen, monitored, documented, reported, and archived.
View toolkit2.3
76
Toxicology Study Planning & Management
Manage toxicology studies and interpret key findings for regulatory and FIH readiness.
View toolkit2.4
65
Safety Pharmacology Program
Assess safety pharmacology risks, including cardiovascular, respiratory, and CNS risk.
View toolkit2.5
65
Genetic Toxicology Program
Plan, track, and interpret genotoxicity study results.
View toolkit2.6
65
Reproductive & Developmental Toxicology Program
Plan reproductive and developmental toxicology work where relevant to population, indication, and stage.
View toolkit2.7
65
Immunotoxicity & Biologics Nonclinical Safety
Support immune-active products, biologics, monoclonal antibodies, and immunomodulators.
View toolkit2.8
64
Local Tolerance & Special Toxicity Studies
Manage route-specific and product-specific special toxicity studies.
View toolkit2.9
66
Bioanalysis and TK/PK Oversight
Govern bioanalytical methods, toxicokinetic sampling, and PK/TK evidence.
View toolkit2.10
66
Nonclinical Data Standards / SEND Readiness
Prepare nonclinical data packages for submission-readiness and study data standards.
View toolkit2.11
65
Nonclinical Report Review & Submission Package
Review, QC, organise, and trace nonclinical reports for IND/CTA/CTD use.
View toolkit2.12
75
First-in-Human Risk Assessment & Starting Dose
Justify starting dose, escalation, stopping rules, sentinel dosing, and safety review governance.
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