Integrated Regulatory Services for Radiopharmaceutical Programs
Radiopharmaceutical developers face regulatory hurdles that don’t show up in standard development journeys. Facet specializes in just that, guiding radiopharmaceutical developers through the FDA requirements unique to positron emission tomography (PET), single-photon emission computed tomography (SPECT), and theranostic products.
How Facet Supports Diagnostic & Theranostic Radiopharmaceutical Development
Facet’s in-house nonclinical, chemistry, and clinical teams have helped emerging companies, hospitals, medical centers, and universities navigate every stage of radiopharmaceutical development, from first-in-human studies through post-marketing support, including:
- Strategic development planning for new radiopharmaceutical drugs, 505(b)(2) products, and generics, built around the dosimetry and half-life constraints unique to radiopharmaceutical agents
- US Agent representation and FDA meeting support
- IND and NDA authoring written with the FDA reviewer’s priorities in mind
- Regulatory and development support for key areas, including drug substance, drug product, and precursor manufacturing considerations, safety margins, dose selection and optimization, imaging protocols, imaging endpoints, statistical analyses, etc.
- eCTD preparation and submission leadership
- Breakthrough designation, orphan designation, rare pediatric disease designation, and user fee waiver authoring for eligible programs
- Pre-approval inspection readiness, evaluation, and support
With regulatory experience across drugs, biologics, medical devices, and combination products, the team designs regulatory pathways based on product-specific data and existing public evidence.
See how Facet saved a European PET radiopharmaceutical developer ~2 years and $5+ million dollars using existing data in the public domain as the basis for FDA approval.
Ground Your Regulatory Strategy in FDA Standards
We know that radiopharmaceutical products’ nonclinical and CMC programs are not standard drug or biologics programs. Small science teams might not have enough in-house bandwidth to ask and answer questions critical to successful FDA outcomes.
That’s why Facet works with your team to build right-sized regulatory and development pathways for each radiopharmaceutical program.
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