Regulatory Guidance
Cyclomedical can provide a full suite of regulatory services, including
- Consultation with regulatory bodies in any country for radiopharmaceutical production, radiation safety, microbiology, and personnel health and safety
- Quality Control Laboratory qualification to cGMP standards
- Complete documentation for radiopharmaceutical production, including proprietary Standard Operating Procedures which are customized for each site
- Full documentation of compliance with applicable regulations
- aNDA submission to USFDA
Cyclomedical has a history of strong relationships with regulators, including providing consulting services where regulations are being established or upgraded to include nuclear medicine.
