Ceutical Laboratories can become your liaison with the FDA and other world-wide regulatory agencies and assist you from product concept through marketing and distribution.

Ceutical Laboratories has the staff and capability to help you every step of the way.

• Register your product and facilities with the FDA
• Provide design control assistance and documentation
• Provide expert 510(K) and PMA submissions, either in part or in total
• Track our submissions through the FDA to ensure quick review and timely notification
• Assist in all regulatory requirements for your submission to assure success through
  • Biocompatibility studies
  • Shipping tests
  • Aging studies/stability studies
  • ISO/ASTM/AAMI tests
  • Product verification studies
  • Product validation studies
• Ceutical Laboratories manufacturing facilities will ensure complete and thorough technology transfer through process validation and first article inspections to meet your needs and requirements