Services
At ClearPath Reg, we care about helping teams bring meaningful therapies to patients. With over 20 years of experience across the biotechnology and pharmaceutical sectors, our regulatory expertise and ability to develop innovative strategies can help you navigate an evolving regulatory landscape with confidence. We focus on delivering practical and tailored solutions that support your business goals.
Whether you need additional capacity for your team, guidance through complex regulatory requirements, hands‑on compliance support, or a tailored regulatory strategy, ClearPath Reg can provide personalised support at every stage to help you achieve regulatory success.
We are honest, ethical and highly motivated to support you throughout your regulatory journey.
REGULATORY STRATEGY
A well‑designed regulatory strategy is essential to maximising the success of your project. We work with you to develop a focused, practical approach that aligns with your business goals and positions your product for regulatory success.
Our services include:
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Providing you with technical expertise in the registration process for both Australia and New Zealand
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Developing regulatory strategies across all stages of product development, commercialisation, and lifecycle management
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Translating global regulatory strategies into effective local approaches for Australia and New Zealand
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Conducting due‑diligence reviews of regulatory to support compliance with local regulations
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Determining the most appropriate registration pathway, including Standard, Orphan, Priority, Provisional, Project Orbis or ACCESS
PROJECT MANAGEMENT
Effective project mapping and ongoing oversight are essential to achieving strong regulatory outcomes. We support you by tracking progress, maintaining alignment, and ensuring clear communication across your local and global teams.
Our services include:
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Developing and maintaining project plans with clearly defined regulatory milestones and timelines
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Communicating regulatory plans and expectations to local and global stakeholders
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Managing cross‑functional teams to keep regulatory activities on track and aligned with strategic objectives
High‑quality regulatory applications reduce the number of agency questions, strengthen the likelihood of approval, and accelerate overall timelines. We support you by preparing, reviewing, and refining your submissions to align with regulatory requirements.
Our services include:
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Preparing regulatory applications and drafting responses to agency questions
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Coordinating meetings with regulatory agencies and managing requests for written advice
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Preparing submissions for Orphan, Priority, and Provisional designations
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Supporting work‑sharing applications, including Project Orbis
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Updating clinical documentation such as Investigator Brochures, patient diaries, patient alert cards, and clinical trial notifications
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Managing post‑approval lifecycle activities, including indication and line extensions, Category 3 applications, and a wide range of notifications and variations
OPERATIONAL REGULATORY SUPPORT
REGULATORY COMPLIANCE
Robust regulatory processes are essential for maintaining compliance and supporting successful internal and external inspections. We help you build and update systems and processes to maintain regulatory compliance.
Our services include:
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Developing and implementing regulatory systems and processes
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Reviewing existing systems and processes to identify gaps and opportunities for improvement
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Providing support and preparation ahead of internal or external regulatory inspections
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Managing post‑approval commitments and associated activities
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Preparing and reviewing Risk Management Plans (RMPs), including Australian‑Specific Annexes (ASAs)