Target product profiles (TPPs): human and veterinary and co-development

Indication selection and prioritization

Gap analysis and development planning

Human–veterinary co‑development strategies

Go/no-go analysis and recommendations

In vitro and in vivo study strategy and design, including NAMs

Novel and established model selection

Non‑GLP and GLP pathway planning and management,

IND‑enabling and Target Animal Safety (TAS)/pilot and pivotal trial design, all species

Regulatory strategy (FDA/CVM, EMA/CVMP, MHRA/VMD, TGA/APVMA)

Authoring meeting requests pre-IND meeting submissions (A-D), INTERACT, EU ITF, scientific advice submissions

Agency meeting preparation and sponsor support and representation; agency response

Designations, human and veterinary (ODD (EU and FDA), FTD, PRIME, MUMS, Conditional Approval (+ Expanded CA), Accelerated Assessment,, Priority Assessment etc.)

Ethics (IRB/IACUC/AEC) applications, animal welfare and governance advice; protocols, reporting and amendments

Independent GLP, VICH-GCP compliance audits

CRO selection and bid defence, Gantt timelines

Independent vendor engagement and oversight, study monitoring

Risk management and CAPA support

Sponsor‑side representation and compliance audits