FDA Regulatory and Quality System Consultants. Assisting Manufacturers and Distributors with FDA Regulatory. Services in USA, Asia and Europe. We deliver excellent value for your regulatory and quality. Assurance needs to market your medical devices and medical components. FDA Delays eCTD Requirements for Master Files and Biological Files. FDA set date for Electronic Submission. FDA draft guidance for Medical Devices.

Smith Associates, FDA Consultants. Consultants Specializing in Regulatory Affairs for FDA Compliance. Smith Associates is located 20 minutes from FDA enabling quick response to FDA during interactive reviews.

FDA and International Consulting and Training Services. So Cal - Tourist Info. Medical Device Training to be held at Disneyland Resort! Expert Consultants ready to assist with your compliance needs! Medical Device Regulatory Submissions cleared quickly! Over 25 years of hands-on experience allows us to help our clients navigate the regulatory and compliance issues faced on a daily basis as well as occasional unwanted surprises encountered.

In 2016 we formed a partnership with Jennings O Donovan and Partners Ltd.

Solving FDA Legal Challenges for the Life. Of a Life Sciences Company. How we help solve FDA legal challenges. For the life of a life sciences company. Occasional musings on new developments. In the regulation of life sciences companies. Law Offices of Michael A. 12519 El Camino Real, Suite E, San Diego, California 92130.