Advancement of Life-Changing Therapeutic Medicines for Rare Disease
Deep scientific expertise, regulatory agility and strategic foresight to navigate the complexities of drug development, accelerating innovation into approved therapies.
Deep scientific expertise
RareGeniX empowers innovators to overcome the hurdles of drug development, transforming brilliant science into life-changing therapies for patients worldwide.
What we deliver
RareGenix provides a comprehensive suite of services designed to address the unique challenges of biotherapeutic development:
- Preclinical & CMC Development: Focused on preclinical research design and manufacturing development, scale up and commercialization.
- Early Regulatory Strategy Development: Defining robust regulatory strategies from the outset and maximizing your chances of success though regulatory interactions with relevant health authorities.
- Risk Based Quality Support: Tailored Quality support that scales with your organization covering vendor support, QMS, audits and batch release.
- Efficient Clinical Trial Design: Streamlined clinical trial strategies, including adaptive designs and decentralized trials, tailored to rare disease research.
- Virtual Leadership: Access to experienced professionals providing technical, strategic and patient centric operational support on an as-needed basis.
Who we support
RareGenix partners with a diverse range of clients across the biopharmaceutical spectrum, including:
- Venture & Private Equity: We provide technical, regulatory and quality due diligence for in-licensing or acquisition.
- Incubator-stage startups: We provide foundational support and guidance to help translate groundbreaking science into viable therapeutic products.
- Emerging biotechs: We augment lean teams with virtual leadership and strategic expertise, enabling them to navigate critical development milestones.
- Established organisations: We offer specialized expertise across defined domains to support and optimize existing processes and accelerate the development of innovative therapies.
Why us?
RareGenix is a consultancy specializing drug development. We are:
- Strategic Partners: We go beyond simply providing advice. We become integral members of your team, working collaboratively to achieve your goals.
- Experienced Navigators: Our team possesses deep expertise in Global Regulatory Affairs, CMC, Quality Assurance and Clinical Development and Patient Engagement.
- Innovation Accelerators: We empower you to make smarter decisions and accelerate your development timelines through tailored strategies and efficient execution.
- Patient-Focused Advocates: We are driven by the shared goal of bringing life-changing therapies to patients in need.
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Contact
Feel free to reach out if you want to collaborate with us, or simply chat.
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