Advise on Australian Strategy
Assess the Australian regulatory pathway, timing, interfaces and practical implications for the development program.
Australian Regulatory Consultancy
About Tricode Clinical
Tricode Clinical is a specialist Australian regulatory consultancy supporting pharmaceutical, biotechnology and other life-sciences organisations across clinical development, regulatory strategy, Australian clinical trial start-up, including OGTR interactions where relevant, marketing authorisation and approved product lifecycle activities.
Tricode was founded by Peter Lynch, an Australian regulatory affairs leader with more than 25 years of experience across government, pharmaceutical, biotechnology, global CRO and consulting environments.
Company Model
A Specialist Australian Regulatory Consultancy
Tricode supports defined Australian regulatory workstreams from early planning through execution and change. The focus is practical Australian clinical-development and market-entry support that reflects the sponsor’s product, pathway, program and operating model.
Tricode is independent of any particular CRO, site network or referral model and can work with the sponsor’s selected providers.
This allows an Australian regulatory workstream to be established around the sponsor’s existing global and regional infrastructure, with responsibilities defined for the work Tricode is appointed to undertake.
Operating Approach
How Tricode Works
Engagements are structured around the Australian regulatory support required and the sponsor’s existing team and providers.
Take Responsibility for a Defined Workstream
Undertake an agreed Australian regulatory workstream with clear scope, responsibilities and decision points.
Integrate With Existing Teams and Providers
Work alongside sponsor teams, CROs, sites and specialist providers without requiring the established model to be replaced.
Maintain Continuity as the Program Develops
Adapt the Australian regulatory workstream as the program, sites, providers or product stage changes.
Founder & Managing Director
Peter Lynch
Founder & Managing Director
Peter Lynch is an Australian regulatory affairs leader with more than 25 years of experience across government, pharmaceutical, biotechnology, global CRO and consulting environments.
His career includes serving as a Group Manager within the Drug Safety and Evaluation Branch at the TGA and later leading Regulatory Affairs across APAC within a global CRO.
His experience includes Australian clinical development and study start-up, TGA regulatory strategy and marketing authorisation, OGTR and advanced therapies, international regulatory programs and approved product lifecycle activities.
Experience
Areas of Regulatory Experience
International Sponsors
Working With International Sponsors
Tricode can support an Australian workstream before the overall outsourcing model is settled, integrate with existing CROs, sites and specialist providers, and undertake defined Australian regulatory responsibilities as the program develops.
Australian work can begin before the complete outsourcing model is finalised. Sponsors can retain established CROs and providers while defining the Australian responsibilities that Tricode is appointed to undertake.
Core Services
Australian Regulatory Support
Explore the service area most relevant to your Australian program.
Clinical Trial Regulatory SupportAustralian feasibility, CTN or CTA, ethics and study start-up support.→
Australian Local Sponsor & Regulatory AgentDefined Australian sponsor and regulatory representation arrangements.→
OGTR & Advanced TherapiesAustralian gene technology and advanced-therapy regulatory support.→
TGA Marketing Authorisation & LifecycleAustralian registration strategy and approved product lifecycle support.→
Planning an Australian Regulatory Workstream?
Discuss the Australian strategy, scope and support model appropriate for your program.
