Regulatory Affairs Support, done for you, done right, done on time.
In need of Regulatory Support?
Deluxe Dossier is a collective of Regulatory Affairs Professionals with a proven ability to use and apply technical standards, principles, theories, concepts, and techniques. We are very dedicated and can multi-task and meet or exceed deadlines. We are experienced in medical device global regulatory filings (Including U.S. and EU) for Class I, Class II, Class IIa & Class III medical devices. We provide Regulatory Affairs Consulting services as well as Regulatory Affairs training.
Services Offered
510(k) Writing and Prep
Do you need help with writing your 510(k) for your medical device? We can help you with that!
Regulatory SOP Writing and Editing
Building out your QMS? We can help you write new SOPs or assist in editing the ones you have.
Regulatory Affairs Consulting
Need a general Regulatory Consultant to help with things as issues arise? We’ve got you!