Services
At ClearPath Reg we provide exceptional support based on 20+ years of regulatory experience in the biotechnology and pharmaceutical sectors. We are here to help you determine the best regulatory strategy to navigate the complex regulatory environments.
We are honest, ethical and highly motivated to help you at each stage of your product lifecycle.
REGULATORY STRATEGY
Having the right regulatory strategy will maximise your project success. We can help create a focused strategy to support your business goals.
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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Brainstorming and development of regulatory strategies across all stages of product development, product commercialisation and life-cycle management
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Implementation of global regulatory strategies into the local regulatory environment (Australia and New Zealand)
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Review of regulatory applications (due diligence) to support compliance with local regulations
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Determination of the right registration pathway: Standard, Orphan, Priority, Provisional, Project Orbis or ACCESS
PROJECT MANAGEMENT
Mapping new and monitoring ongoing projects will support regulatory outcomes. We can help track and communicate your plans to your local and global teams.
Our services include:
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Development and maintenance of project plans with clearly defined regulatory milestones and timelines
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Communicating your clear regulatory plans to your local and/or global stakeholders
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Project management of cross functional teams
High quality applications will minimise the number of questions, increase the likelihood of regulatory success and accelerate regulatory approvals. We can help create and review your regulatory applications.
Our services include:
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Preparation of regulatory applications and responses to agencies questions
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Meetings with regulatory agencies or requests for written advice
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Orphan, priority, provisional designations
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Work-sharing applications, such as Project Orbis
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Updates to clinical documents, such as Investigator Brochures, patient diaries, patient alert cards, or clinical trial notifications
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Post-approval life-cycle management: including but not limited to indication, line extensions, Category 3 applications and assorted notifications and variations
OPERATIONAL REGULATORY SUPPORT
REGULATORY COMPLIANCE
Having robust processes in place ensures compliance and increases the likelihood of success of internal or external regulatory inspections. We can help you create or update your regulatory systems and processes to maintain compliance.
Our services include:
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Development and implementation of regulatory systems and processes
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Review of your regulatory systems and processes
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Providing support prior to planned internal or external regulatory inspections
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Post approval commitments project management
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Risk Management Plans (RMP): RMP review and Australian Specific Annex (ASA) preparation