Navigating Regulatory Challenges, Accelerating Innovation and Patient Access
Rubicon is a regulatory consulting firm specializing in the life sciences and biopharmaceutical industries, offering customized end-to-end regulatory solutions throughout a product's lifecycle. Rubicon adapts to your evolving regulatory needs, providing tailored support at every stage to accelerate timelines, ensure compliance, improve outcomes, and expedite patient access to innovative therapies.
Unlock your Strategic Roadmap
An effective regulatory strategy is key to navigating the complex drug development landscape. Developed early and maintained throughout a product's lifecycle, a comprehensive regulatory strategy guides decision-making, resource allocation, risk management, and fosters collaboration with internal and external stakeholders.
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Most importantly, it creates a roadmap that accelerates patient access to safe, effective, and high-quality therapies. With over 20 years of clinical and regulatory expertise, Rubicon helps you build a tailored strategy to drive success at every stage of development.
Our Regulatory Services
Health Authority Interactions
Regulatory Designations
Regulatory Operations
Pediatric Plans
Competitive Intelligence
Project Management
Labeling Support
Inspection Readiness
Expertise Across Multiple Modalities
Rubicon leverages over 20 years of regulatory and clinical expertise across multiple modalities, including pharmaceuticals, biologics, and Human Cell and Tissue-Based Products (HCT/Ps) to support your program's regulatory needs.
Pharmaceuticals
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Small molecules
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Peptides
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Enzyme replacement therapies
Biologics
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Monoclonal antibodies
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Antibody drug conjugates
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Biosimilars
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Vaccines
HCT/Ps
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Somatic cell therapies
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Tissue engineering therapies
A Foundational Partnership
A trusted regulatory partner throughout the drug development process can make all the difference. We leverage our extensive experience to listen and understand your product and its lifecycle needs. We partner with you to help develop your strategic vision, plan for success, and execute on the details. Our experience has taught us that investing in a robust regulatory strategy from the start is more than just prudent, it is often the missing catalyst for success.
