Regulatory Consulting for Life Sciences & Biopharma Innovation
Rubicon is a trusted provider of regulatory consulting for life sciences and biopharmaceutical companies, offering customized end-to-end support across the product lifecycle, from early discovery through post-market surveillance.
Rubicon specializes in providing regulatory support within the biopharmaceutical industry, helping clients address the evolving regulatory landscape with tailored strategies and expert guidance. With extensive experience with global regulators, including the FDA, EMA, PMDA, and other international regions, Rubicon provides a concise regulatory plan that aligns with your product’s clinical development strategy and facilitates clear communication with global health authorities.
Rubicon provides regulatory strategic support for investigational products across the drug development lifecycle, from INDs/CTAs through to global marketing authorizations. Our mission is to accelerate biotech product approvals, improve patient access, and deliver high-impact outcomes through end-to-end regulatory services.
Regulatory Planning for Drug Development Success
A proactive, well-defined regulatory strategy is crucial for navigating the complexities of drug development in the life sciences and biopharmaceutical industries. At Rubicon, we develop integrated strategies early in the product lifecycle to guide decision-making, resource allocation, and regulatory interactions.
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Our services help you develop a global regulatory strategy, manage risk, and shorten development timelines. With decades of experience in drug development, Rubicon supports your journey from IND/CTA preparation to marketing authorization, accelerating your path to approval. A proactive, well-defined regulatory strategy is crucial for navigating the complexities of drug development in the life sciences and biopharmaceutical industries. Rubicon develops integrated strategies early in the product lifecycle to guide decision-making, resource allocation, and regulatory interactions.
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Rubicon’s services help you align your global regulatory strategy across regions, including FDA and EMA, as part of your global footprint, manage and mitigate risk, and shorten development timelines. With decades of experience in drug development consulting, Rubicon supports your journey from IND/CTA preparation to marketing authorization, accelerating your path to approval.
Regulatory Services
Health Authority Interactions
Regulatory Designations
Regulatory Operations
Pediatric Plans
Competitive Intelligence
Project Management
Labeling Support
Inspection Readiness
Regulatory Expertise Across Drug Modalities
Rubicon brings over 20 years of regulatory consulting for life sciences and biopharma regulatory support, with deep experience across diverse therapeutic modalities—including pharmaceuticals, biologics, and Human Cell and Tissue-Based Products (HCT/Ps). Our team delivers end-to-end regulatory services that adapt to the unique development and compliance needs of each product type.
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 Trusted Regulatory Partner from Discovery to Approval
Choosing the right regulatory consulting for life sciences and drug development partner can mean the difference between costly delays and streamlined progress. Rubicon works closely with biopharma innovators to co-develop customized regulatory strategies that align with global regulatory requirements.
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With comprehensive drug development consulting expertise, Rubicon provides critical support through IND/CTA submissions, clinical development, and marketing authorization. Rubicon’s flexible, full-lifecycle support model allows you to stay focused on innovation while ensuring regulatory readiness.
