|
Keystone Regulatory Services, LLC |
Other Services |
|
Keystone Regulatory Services is a full service consulting organization. In addition to quality system, risk management and premarket regulatory consulting, we can help in a variety of other ways. Our expert witness service can help you prepare for trial. Foreign medical device manufacturers utilize Keystone Regulatory Services as their US Agent. Our experience in 510(k) premarket notifications will ensure the product manufactured overseas gains access to the US market. The small manufacturer may not need a full-time regulatory staff, Keystone Regulatory Services can act as your part time regulatory affairs / quality assurance department until you reach critical mass. Lastly, we can help you protect your investment in new technologies by performing regulatory affairs and quality system-related due diligence prior to acquisition or spin-off. Contact Keystone Regulatory Services for more information on your regulatory needs. |
|
· Expert Witness · US Agent for Medical Devices · Contract Regulatory Officer · Acquisition Due Diligence |
|
To contact us: |
|
342 E. Main St. Suite 211 Leola, PA 17540 |