Regulatory Strategy
Biointelect complement your regulatory team capabilities by offering integrated regulatory guidance and recommendations across all stages of the development cycle, supported by our experienced regulatory affairs consultants.
Our Regulatory Strategy Services
In addition to providing integrative regulatory guidance and recommendations within key milestones of our R&D Strategy and Planning, Commercialisation, and Market Access services, Biointelect’s team of regulatory affairs consultants also provides stand-alone services across all stages of the development cycle.
Biointelect has deep and wide-ranging expertise in developing and mapping a global regulatory strategy with optimal pathways and requirements for conformance.
Our extensive Australian and global network allows us to offer bespoke solutions to complement your regulatory team capabilities, ranging from strategy mapping to implementation, management and maintenance activities.
Early Stage
In this phase, our regulatory affairs team identifies critical regulatory requirements and collaborates with you on strategy early to reduce the risk of delay in late-stage development.
We provide advice within workshops or ad-hoc to guide investment decisions, grant applications, and support trial activities to maximise each value inflection point.
We can develop a high-level product development plan to provide you with a road map and funding requirements.
Growth Stage
This phase involves implementing a well-defined go-to-market regulatory strategy while keeping track of ever-changing global regulations and company requirements, key to commercial success.
We investigate opportunities to apply for special accelerated pathways or parallel authorisations to accelerate and expand product entry. We conduct due diligence to identify gaps or specific national requirements to understand and mitigate regulatory risk and provide recommendations for asset transfers.
Late Stage
As we move closer to market, in this phase, we act as your liaison for direct engagement with regulatory agencies to drive successful product registrations, including representation at agency meetings and negotiation activities.
We help to establish a quality and regulatory framework for compliant and sustainable post-approval success. We also identify and engage with Australian sponsors for clinical trials or product registrations for international partners.
We have diverse expertise in regulatory consulting for biological medicines, vaccines, genetically modified organisms, and medical devices (including IVDs).
Our late stage regulatory consulting services include:
- Regulatory agency liaison
- Regulatory gap analysis and due diligence
- Dossier compilation and submission management
- Competitive intelligence
- Pre-submission meetings
- Comparable overseas regulator (COR) pathways
- ACCESS consortium pathways
- Priority review and abbreviated evaluation pathways
- Provisional registration pathways
- Clinical trial applications
- International regulatory strategy roadmaps, including overview of timelines and costs
Why Biointelect for Regulatory Strategy?
Accessible Regulatory Expertise
Biointelect provides tailored, actionable, fit for purpose guidance for navigating complex regulatory pathways.
Currency and Reliability
Our lived experience and rich international network of senior advisors guide advice to mitigate risk and facilitate optimal clinical and commercial regulatory outcomes for novel therapeutics and technologies.
Global Viewpoint
We harness opportunities for parallel or shared engagement with regulatory agencies to maximise impact.
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Get in Touch
Wherever you are in your new product journey, Biointelect’s unique expertise across each stage of the life science value chain means we are ready to bring your innovative life science to market.
Take the next steps in advancing healthcare for all by contacting our team of local Australian and global life science experts today.
