Regulatory strategy
Clear, practical regulatory pathways aligned with product objectives and the Australian regulatory environment.
Independent regulatory affairs consultancy
Strategic advice.
Regulatory solutions.
Successful outcomes.
Senior, scientifically grounded regulatory support for pharmaceutical and biotechnology companies navigating the Australian regulatory environment.
Independent perspective
Scientific rigour
Practical regulatory advice
How BDH can help
Regulatory expertise,
applied with purpose.
Flexible support for defined projects, complex regulatory questions or additional senior capacity when it is needed.
Submissions and review
Preparation, critical review and refinement of regulatory documentation for robust, coherent submissions.
TGA interactions
Support for agency correspondence, questions and responses, with a focus on scientific clarity and regulatory relevance.
Compliance and gap analysis
Focused assessment of documentation and regulatory readiness to identify priorities, gaps and practical next steps.
Meet your consultant
International experience.
Independent advice.
Brian Hewitt, PhD, brings more than 25 years of pharmaceutical regulatory experience, including senior leadership roles at Pfizer across Australia, New Zealand and international markets. His consultancy combines scientific depth with practical experience in regulatory strategy, submissions, product lifecycle management and team leadership.
Brian’s background and expertise →Start a conversation
Need experienced regulatory input?
Let’s discuss the context, the challenge and the support you need.
Contact BDH Regulatory Consulting →