SERVICES

Adriaus Consulting offers premium services and support across Global Regulatory Affairs, Strategy and Project Management through all stages of product development, commercialisation and life-cycle management for biotechnology, biopharmaceutical, biological and pharmaceutical medicines. Adriana Stefancic, Principal Consultant, will personally provide all consulting services. Her expertise remains focused exclusively in the biotechnology, biopharmaceutical and pharmaceutical medicine industries.

Adriaus Mission

Global Regulatory Affairs

We will take the lead and facilitate with all facets of Global Regulatory Affairs.

This includes:

  • Advice and expertise in regulatory processes and approvals in the United States, Australia, Europe, New Zealand and others. We cover the Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA), the European Medicine Agency (EMA), Medsafe and other Regulatory Agencies.
  • Development, marketing, communication and execution of global Regulatory Strategies across all stages of product development, commercialisation and life-cycle management for biotechnology, biopharmaceutical, biological and pharmaceutical medicines.
  • Oversight, planning, preparation and submission of global regulatory dossiers, such as:
    • Marketing Applications covering Quality/CMC, Nonclinical and Clinical documentation in the Common Technical Document format – including Biologics License Applications (BLA), New Drug Applications (NDA), Category 1 applications, Category 2 applications, Marketing Authorisation Applications and others.
    • Regulatory Agency meeting requests and meeting information packages.
    • Clinical trial applications and variations– including Investigational New Drug (IND) applications, IND amendments, Clinical Trial Exemption applications, Clinical Trial Notifications, Clinical Trial Applications and others.
    • Prescriber and Patient Information documents.
    • Post approval variations – including Category 3 applications, BLA and NDA supplements, assorted variations and notifications, Annual Reports and others.
    • Investigator’s Brochures.
    • Periodic Safety Update Reports.
  • Formulation of strategic responses to Regulatory Agency questions.
  • Review of data packages and regulatory dossiers.
  • Meeting, communication, liaison and negotiation with Regulatory Agencies including the FDA, TGA, EMA, Medsafe and others.
  • Management, oversight and co-ordination of Regulatory Agency meetings.
  • Global and local regulatory intelligence, monitoring and advice on competitors, emerging regulatory trends and assessment of their impact on development programs, projects and products.
  • Regulatory gap analysis (due diligence) for international product opportunities.

Strategy

We will take the lead and facilitate strategies.

Such as:

  • Development, marketing and execution of global Regulatory Strategies across all stages of product development, commercialisation and life-cycle management for biotechnology, biopharmaceutical, biological and pharmaceutical medicines.
  • Development of strategic solutions to issues raised by Regulatory Agencies.
  • Development, marketing and implementation of mid and long-term strategic plans from departmental to executive levels.
  • Development and execution of innovative strategies for problem solving.
  • Review of developed strategies and proposals.

Project Management

We will take the lead and facilitate with Project Management.

This includes:

  • Development, marketing and execution of project plans for all regulatory submissions with clearly defined pathways and milestones that lead to successful outcomes.
  • Development and implementation of communication plans. Achieving buy-in from others for projects plans and strategies including regulators, executives, commercial partners, teams, local and international stakeholders.
  • Development, marketing and implementation of systems and processes that increase operational efficiencies.
  • Review of project plans and proposals.
  • Project management of cross functional teams.
  • Monitoring and when needed, correcting project progress.