Nonclinical and regulatory consulting, with a difference

Independent expertise across the nonclinical lifecycle

Minotaur Pharma provides expert consulting services for complex nonclinical, regulatory, and development challenges, across both human and veterinary drug development.

We work with founders, investors, and biotech/pharma teams who need clear, creative solutions, regulatory-defensible strategy, expedited timelines and highly experienced industry professional for execution and leadership.

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Our Consulting Services

We offer a range of bespoke services to meet the needs of every client.

Have something else in mind?

We'd be happy to work with you to create a tailored solution.

    • 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

How We Work

  • Senior-leadership-led bespoke engagements

  • Independent

  • Practical, agile, actionable plans, within budget

  • Embedded (partial FTE) or ad hoc advisory support

Let’s Work Together

If you're interested in working with us, complete the form with a few details about your project. We'll review your message and get back to you within 48 hours.