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