SERVICES

Adriaus Consulting offers premium services and support in global and regional regulatory affairs, regulatory strategy and executive regulatory advice for prescription medicines. We also offer tailored training and coaching in regulatory affairs. All of our services are provided in a timely manner.

Adriaus Mission

Global and Regional Regulatory Affairs

We offer specialist skills in global and regional regulatory affairs and provide advice and expertise for prescription medicines across a wide range of therapeutic areas that are targeted for the FDA, TGA, Medsafe, EMA, MHRA and other Agencies. We lead, facilitate, prepare and project manage all types of global regulatory submissions. We liaise, meet and negotiate with Regulatory Agencies to achieve the best possible outcomes and product labelling.

Our services (covering the FDA, TGA, Medsafe, EMA, MHRA & other Agencies):
  • Advice and expertise in regulatory pathways, processes and approvals.
  • Planning, preparation, project management, submission and oversight of regulatory dossiers, such as:
    • Marketing authorisation applications in the Common Technical Document (CTD) format, including regional Module 1 documents.
    • Applications necessary during the pre-submission phase.
    • Clinical trial applications, including Investigational New Drug (IND) applications.
    • Post approval variations.
    • Facilitation of eCTD publishing.
  • Interpretation and preparation of responses to regulatory questions.
  • Project Management of submissions through various regulatory pathways and during life-cycle management.
  • Leadership, management and chairing of Regulatory Agency meetings, including preparation of meeting requests, information packages, negotiation at Agency meetings.
  • Provision of global and regional regulatory intelligence, advice on competitors, emerging regulatory trends and their impact on our client's program/product.
  • Development and implementation of systems and processes that increase our client's operational efficiencies.
  • Ongoing collaboration with global and regional project stakeholders.

Regulatory Strategy

Drawing on our extensive and in-depth regulatory experience, as well as many years of work at the interface with commercial, we aim to solve your problems by developing and implementing innovative global or regional regulatory strategies for product development and commercialisation programs that make both regulatory and commercial sense. Throughout the entire process, we collaborate closely with your stakeholders.

Our services include:
  • Development, communication and execution of global and regional regulatory strategies and frameworks across all stages of product development, commercialisation and life-cycle management for prescription medicines.
  • Review and refinement of medicine development plans from preclinical through to clinical development, dossier compilation/submission/review/approval and commercialisation.
  • Development and execution of innovative strategies for problem solving.
  • Leadership and development of the Target Product Profile.

Executive Regulatory Advice

We offer comprehensive executive regulatory advice to help your executives and company boards make the best decisions. From strategic opinion on specific issues to in-depth evaluations and opinions on Agency requirements and regulatory pathways that you may be thinking about. We offer advice on regulatory matters relating to key Regulatory Agencies (FDA, TGA, EMA, MHRA, Medsafe).

Our services include:
  • Strategic regulatory input for executive and company board meetings.
  • Advice and assessment of various regulatory pathways for informing executive decision-making (e.g. FDA 505 (b)(2) NDA pathway, FDA accelerated approval pathway).
  • Review and advice on development programs.
  • Review and advice of available regulatory public information for use in commercial models for executive decision-making.

Training and Coaching

For your program to be successful, your teams or individuals may need to receive training or coaching in regulatory issues. Among our services are the design and delivery of customised regulatory affairs training and coaching programs. Contact us about your training or caching needs if not listed below and we can tailor a program.

Training services:
  • CTD dossier training covering all modules. Examples include:
    • Module 3 content and inter-relationships of sections, undertaking due diligence/gap-analysis, post approval variations.
    • Module 1 content, preparation of product labelling, writing cover letter and notes to reviewer, project management of preparing Module 1 sections.
  • Preparation and rehearsals for meetings with Regulatory Agencies (FDA, TGA, Medsafe, EMA, MHRA).
  • Benefits/limitations on various regulatory pathways available in key regulatory jurisdictions.
Coaching services:
  • Executive coaching of senior team members in strategic aspects of regulatory affairs such as leadership and project management of regulatory projects, preparation and chairing of Regulatory Agency meetings.
  • Coaching of individual members to upskill in regulatory affairs in areas needed for your program/project.
  • Support and guidance of individuals to increase competencies in regulatory affairs.