Adriaus Consulting

Strategic Global Regulatory Advisor for Biotech, Biopharma, Pharma & Vaccines

Adriaus Consulting

Accelerating approvals. Reducing regulatory risk. Supporting global commercialisation.

Adriaus Consulting partners with biotechnology, biopharmaceutical and pharmaceutical companies to navigate complex global regulatory pathways and achieve approvals across major markets.

With deep experience navigating the Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA), the European Medicines Agency (EMA), Medsafe and other regulatory agencies, we support programs from early development through to commercialisation and lifecycle management.

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What We Do

We help you:

Define the optimal regulatory pathway to approval
Align regulatory strategy with commercial outcomes
Navigate complex, multi-region regulatory requirements
Achieve faster approvals and support successful commercialisation

Why Adriaus Consulting

Proven FDA success - including Biologics License Application approval in 6 months
Experience in high-stakes programs - COVID-19 and influenza programs
Experience in diverse therapeutic areas - approval of multiple medicines
End-to-end expertise - from preclinical through to commercialisation
Senior-level engagement - all work led directly by a highly experienced principal

We don't just advise - we deliver outcomes when it matters most

How we can help:

GLOBAL & REGIONAL REGULATORY AFFAIRS

Strategic leadership and execution of regulatory submissions and agency engagement across all major jurisdictions.
IND, CTA, BLA, MAA, Cat 1 | CTD dossiers | Agency meetings | Lifecycle management

REGULATORY STRATEGY

Development of clear, commercially aligned regulatory strategies that reduce risk and accelerate development.
Pathway optimisation | Development planning | Risk mitigation

EXECUTIVE REGULATORY ADVICE

Independent, high-level advice to support executive and board decision-making.
Regulatory pathways | Gap analysis | Strategic risk assessment

TRAINING & COACHING

Tailored programs to strengthen regulatory capability across teams and individuals.
CTD training | Agency preparation | Executive coaching

PRINCIPAL CONSULTANT

Adriana Stefancic is the Founder and Principal Consultant of Adriaus Consulting and she has over thirty years of successful experience working with global regulatory agencies and substantial experience at the regulatory/commercial interface.

Proven Experience:

Led COVID-19 vaccine regulatory approvals (AU/NZ) during the pandemic
Achieved FDA BLA approval in 6 months (US)
Co-led regulatory strategy for pandemic influenza programs (AU/US)
Delivered multiple TGA and Medsafe approvals (AU/NZ) to commercialise products