"In all our business dealings with Buckman Company, Inc., we found them to be flexible, on-time and on budget -- all done with a high level of personal integrity."

Buckman Company, Inc. is a multi-specialty provider of FDA oriented regulatory services. Our consultants are proficient in strategic planning, document or clinical study authoring, editing and reviewing of FDA required submissions for the purposes of Premarket Approval Applications, Investigational Device Exemptions and Premarket Notifications [510(k)]. Supplemental areas of expertise include Good Clinical Practices, ISO 9000 qualification, Good Manufacturing Practices, QA/QC audits, expert testimony and due diligence processes.

Several of our consultants have successfully transitioned from a direct-care clinical background to the business world. This unique combination is effective in bringing an immediate "no nonsense" practical approach to our clients' regulatory strategic plans.

Services are provided to national and international medical device manufacturers, consultants, product development companies, attorneys, focus groups and consumer oriented associations.

Industry areas are cardiovascular, orthopaedic, neurologic, dental, drug delivery systems, disposables, OTC products, endoscopic equipment and lasers for multiple uses including ophthalmic, refractive, dermatologic and percutaneous procedures. Fees are quoted on an hourly, task or project/retainer basis.