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.