Radiopharmaceutical Solutions fromthoughttofinish
Radiopharmaceutical Solutions
The radiopharmaceutical industry is experiencing a renaissance, with unprecedented growth resulting from rapid advancements in targeting radiation through new therapies and increasing global investment. As radiopharmaceutical innovation accelerates, so do regulatory complexities.
ELIQUENT is a trusted partner to global radiopharmaceutical innovators. We understand the unique challenges and opportunities facing radiopharmaceutical innovators.
We understand the unique challenges and opportunities facing radiopharmaceutical innovators. Our deep expertise, proven track record, and industry-first approach make us the ideal partner to guide radiopharmaceutical innovators through regulatory, quality, and safety requirements—ensuring efficient approvals and long-term compliance.
Strategic & Technical Capabilities
Unlike conventional pharmaceuticals, radiopharmaceuticals present unique regulatory, technical, and logistical challenges. Our expertise enables us to tackle the most critical challenges in radiopharmaceutical development and compliance with precision and efficiency.
ELIQUENT’s integrated regulatory, quality, and safety solutions are designed to support companies bringing their products to market and maintaining global compliance. Whether you’re developing a first-in-class radiopharmaceutical or managing the post-approval lifecycle of an existing product, ELIQUENT provides the expert guidance to ensure regulatory success.
Expert Team
ELIQUENT’s team of radiopharmaceutical experts – composed of professionals with firsthand experience in radiopharmaceutical regulatory pathways – collaborate seamlessly to unlock excellence across the product lifecycle.
Our proven track record of success in navigating complex regulatory landscapes makes us a trusted partner for radiopharmaceutical companies seeking strategic guidance, streamlined approvals, and long-term compliance solutions.
Specialized Solutions
ELIQUENT appreciates the specialized regulatory approach required by radiopharmaceuticals – one that accounts for complex oversight, short-lived isotopes, evolving global requirements, and cutting-edge scientific advancements.
Our team of former regulators, industry leaders, and scientific experts has the hands-on experience and deep knowledge needed to help radiopharmaceutical companies navigate these unique challenges efficiently and successfully.
Dual Regulatory Oversight
Managing Health and Nuclear Regulatory Requirements
The Challenge.
Unlike conventional pharmaceuticals, radiopharmaceuticals fall under both health and nuclear safety regulations, requiring companies to coordinate with multiple regulatory bodies.
Our Solution.
The ELIQUENT team has extensive experience harmonizing regulatory strategies that align both drug approval requirements and nuclear safety regulations.
Global Market Differences
Varying Regulatory Expectations Across Regions
The Challenge.
Regulatory requirements for radiopharmaceuticals vary widely between the United States, European Union, and Asia-Pacific, making global expansion difficult. A tailored approach is optimal.
Our Solution.
ELIQUENT provides tailored global regulatory strategies to meet country-specific requirements while maintaining efficiency.
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FDA and EMA radiopharmaceutical guidelines alongside NRC and European national radiation safety requirements
U.S. and Europe-specific Good Manufacturing Practices (GMP) for radiopharmaceutical production to ensure compliance
Country-specific variations in regulatory expectations for the transport, storage, and handling of radioactive materials
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With expertise in region-specific submission pathways, ELIQUENT works with clients to streamline submissions, including:
Investigational New Drug (IND) applications in the U.S.
Clinical Trial Applications (CTA) in Europe
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) processes
Post-approval support to expand already-approved products into new territories seamlessly
Emerging Science & Innovation
Staying Ahead of Regulatory Trends for Novel Therapies
The Challenge.
The field of radiopharmaceuticals is evolving rapidly, particularly in theranostics and radiotherapeutics. Companies must proactively anticipate shifting regulatory expectations to avoid unnecessary delays in approvals.
Our Solution.
ELIQUENT works with companies to proactively anticipate shifting regulatory expectations to avoid unnecessary delays in approval. Our experience enables the delivery of valuable insight throughout the product lifecycle.
Short Half-Life & Logistics Challenges
Precision in Manufacturing and Clinical Trials
The Challenge.
Many radiopharmaceuticals have extremely short half-lives, requiring precise coordination between manufacturing, distribution, and administration to patients in clinical trials and commercial settings. The supply chain must be tightly controlled to avoid delays that could render the product unusable.
Our Solution.
ELIQUENT understands the time-sensitive nature of radiopharmaceuticals and offers regulatory strategies and expert guidance to optimize essential timelines.
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Deep expertise in regulatory pathways for next-generation radiopharmaceuticals, including dual-purpose (therapeutic and diagnostic) products
Strategic agency engagement to ensure regulators understand and support new approaches to radiopharmaceutical development
Proactive risk mitigation to address evolving regulatory guidance on combination products, dose optimization, and clinical endpoint design
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Optimization of submission timelines to align regulatory approvals with commercial launch readiness
Regulatory strategies for just-in-time manufacturing and decentralized distribution models
Expert guidance on compliance with stability testing and shelf-life requirements
Global Solutions
Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.
United States
ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.
Europe
The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.
Asia
ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.
Explore ELIQUENT Japan >>