SERVICES

The team at Adriaus Consulting offers premium services and support in Global Regulatory Affairs, Regulatory Strategy and Project Management through all stages of product development, commercialisation and life-cycle management for vaccines, biological, biotechnology and pharmaceutical medicines.

Adriaus Mission

Global Regulatory Affairs

We offer specialist skills in Global Regulatory Affairs, including regional Regulatory Affairs, and provide advice and expertise in regulatory processes of the FDA, EMA, TGA, Medsafe, MHRA and others. We lead, facilitate and prepare all types of global regulatory submissions. We liaise, meet and negotiate with Regulatory Agencies. We communicate and enlist your teams on pathways to success. We monitor international regulatory trends and assess their impact on development projects, programs and products.

Our services include:
  • Advice and expertise in regulatory processes and approvals covering the FDA, EMA, TGA, Medsafe, MHRA and others.
  • Planning, preparation and submission of global regulatory dossiers, such as:
    • Marketing Authorisation Applications covering Quality/CMC, Nonclinical and Clinical documentation in the Common Technical Document format – including FDA’s Biologics License Applications (BLA) and New Drug Applications (NDA), TGA’s Category 1 applications, EMA’s and MHRA’s Marketing Authorisation Applications (MAA) and others.
    • Clinical trial applications– including Investigational New Drug (IND) applications and amendments, Clinical Trial Applications and notifications, and others.
    • Prescriber and Patient Information documents.
    • Post approval variations – including Category 3 applications, BLA and NDA supplements, assorted variations and notifications.
    • Planning and preparation of Investigator’s Brochures.
    • Preparation of responses to regulatory questions.
    • Management and co-ordination of Regulatory Agency meetings. Preparation of Regulatory Agency meeting requests, meeting information packages and leadership of meetings.
    • Communication, liaison and negotiation with Regulatory Agencies including the FDA, TGA, EMA, MHRA, Medsafe and others.
    • Global and regional regulatory intelligence, monitoring and advice on competitors, emerging regulatory trends and their impact on your program/ product.
    • Regulatory gap analysis (due diligence) and identification of deficiencies of full regulatory dossiers and global submissions; all modules Quality/CMC, Nonclinical and Clinical.

Regulatory Strategy

We develop, communicate with client stakeholders and execute Global Regulatory Strategies for product development and commercialisation programs. Using our vast and in-depth experience, we develop and execute innovative strategies to solve your problems.

Our services include:
  • Development, communication and execution of Global Regulatory Strategies across all stages of product development, commercialisation and life-cycle management for vaccines, biological, biotechnology and pharmaceutical medicines.
  • Review and development of medicine development plans, from regulatory perspective, across research and preclinical through to clinical development, dossier compilation/submission/review/approval and commercialisation.
  • Development and execution of innovative strategies for problem solving.

Project Management

We lead, facilitate and project manage complex regulatory submissions that lead to timely submission and successful outcomes. We effectively communicate with your global and regional stakeholders. We develop and implement systems and processes to increase operational efficiencies. We monitor and correct project progress.

Our services include:
  • Development, communication and execution of project plans for all regulatory submissions with clearly defined pathways and milestones that lead to timely submission and successful outcomes.
  • Development and implementation of communication plans. Achieving buy-in from others including your teams, Regulators, executives, commercial partners, local and international stakeholders.
  • Development and implementation of systems and processes that increase operational efficiencies.
  • Project Management of cross functional teams.
  • Monitoring projects and correcting timelines.