FDA Submissions

We Do Good Science and Good Medicine

For those developing Companion Diagnostics or Stand Alone IVD's, FDA approval is often a barrier to success. However, Lakeside's proven regulatory strategy of designing Analytical and Clinical Validation studies that are scientifically and medically sound, leads to safe and effective laboratory tests that truly benefit patients.  FDA approval is EASY - when you do it right!

Don't stare at the endless horizon of FDA submission to-do's without a friend. Let Lakeside design your Regulatory strategy, submit your Presubmission package, design your clinical studies, and prepare your submission packages. Join Lakeside to bring life saving tests to market - and Make it EASY!