PET Radiopharm – One of Our Specialties!
Is a medical device application right for my contrast imaging agent?
FDA will now assess the primary intended action and metabolism of imaging agents to determine the right regulatory pathway.
We understand the special nature of PET radiopharmaceuticals and the organizations that are championing them on behalf of patients.
The Facet Life Science team has more experience with PET Radiopharmaceutical products than any services provider.
Facet has helped medical centers, universities, and small companies successfully move their PET radiopharmaceuticals through all stages of development to marketing approval.
We provide:
- Strategic program guidance and support for new drugs, 505(b)(2) products, and generics
- In-house nonclinical, chemistry, and clinical scientific expertise
- US Agent and FDA meeting support
- IND and NDA document authoring with the FDA reviewer in mind
- Document review for scientific accuracy and compliance
- eCTD preparation and submission
- Authoring of breakthrough designation/orphan designation requests and user fee waivers
- Pre-approval inspection readiness evaluation and support
and have experience with:
- Drugs and biologics
- Medical devices
- Combination products
and offer Gemstone, an everyday document management system that enables you to:
- Securely and easily share information between team members
- Organize your content logically and control versions
- Meet FDA’s requirements for proper documentation practices (21 CFR Part 11)
- Save time and money in the preparation of submissions to FDA
One of our guiding principles is to help you leverage your data and the data in the public domain to secure FDA approval for your PET radiopharmaceutical quickly and inexpensively.
Sara DeMare, MS, of Facet Life Sciences recently presented at a co-sponsored (SNMMI and FDA) PET radiopharmaceuticals workshop on Inspections Management and Regulatory Considerations in Silver Spring, MD. She shared her expertise and insights on critical aspects of CMC applications for radiopharmaceuticals in her session entitled, “Management of PET Drug Applications – PET Community Perspective” in conjunction with Peter Scott, Ph.D. She actively participated in the subsequent panel discussion regarding lifecycle management of PET Drug Applications.
gET sOCIAL