We at Timoney Quality Consultants can expedite your submission by preparing or reviewing the relevant documents in support of your application .Following review by the Regulatory Body ,we  can also address all queries on your behalf .

Examples of Regulatory Documents which we can prepare /review for you include :

  • Site Master file
  • Quality  Manual
  • Product Registrations’ – including PMA ,technical files ,Design Dossiers and 510 K submissions
  • Responding to questions arising from review of submissions by the various Regulatory Bodies
  • Introduction of  Technical Agreements within  Quality System – preparation of SOP and associated Template
  • Introduction of   an  Annual Product Review process within the Quality System and preparation of product reviews
  • 30 day notices and annual reporting