Target Product Profiles & indication selection

Drug development plans - small molecules, biologics, ATMPs

Novel animal models, new approach methodologies (NAMs)

Gap analysis and go/no‑go decision support/fatal flaw analysis

IND-enabling study design, study list optimisation, GLP and non-GLP

Vendor selection, bid defense & management, milestones, budget ownership

Primary/secondary pharmacology, safety pharmacology, PKPD, pivotal toxicology, TK

Bridging toxicology

FIH starting dose justification, biomarkers, stopping rules, safety monitoring

Regulatory strategy, expedited designations, health authority interactions and sponsor representation (pre-IND FDA, Scientific Advice - EMA, TGA, MHRA), EOP2, PSPs, PIPs

Nonclinical author: IBs, IND/NDA/BLA, CTN/CTA, ODDs, pre-IND type B, C, D request, briefing documents

Human–veterinary co‑development strategies, pivoting, repurposing, reformulation

Fractional Head of Toxicology

Due diligence, investor relations

Crisis consulting

Veterinary drug development plans, gap analyses

Feasibility assessment

Management of proof of concept studies and go/no-go advice

Analysis of standard of care, commercial opportunities

Design, conduct and management of veterinary pilot and field studies (VICH-GCP)

PKPD, target animal safety, pilot and pivotal trials (multi-site)

IACUC/IRB/AEC/IBC approvals; site management, study direction

CRO selection and management of GLP studies

Regulator engagement and sponsor representation

Authoring submissions across life cycle

RDTI-facilitating, audit‑ready documentation

Global network of KOLs, cross species and disciplines

Veterinary program architect and scientific advisor

Investor liaison and communications