Excel Regulatory

Category: Regulatory  Sub: Consulting

Summary:

Excel Regulatory Consulting provides regulatory consulting services to medical device companies to obtain FDA approval to market their products. These services include: regulatory strategy planning, submissions such as: 510(k), IDE, or PMA; and negotiation and liaison with FDA. We also assist medical device companies and contract manufacturers in the establishment of FDA-compliant Quality Systems.

Full Description:

It is never too early to plan the regulatory strategy of a medical device. Excel Regulatory Consulting has assisted numerous start-ups as well as established medical device companies to obtain approval of their FDA regulated medical products. We are experienced in the following:

•  Regulatory pathway strategy planning
• Device classification determination
• 510(k), Premarket Notification
• PMA, (Premarket Application)
• Clinical trial management
• Quality System establishment
• Quality audit of manufacturers and contract manufacturers
• FDA inspection counseling

 Excel Regulatory Consulting also offers consulting services for drugs and biologics:

• IND (Investigational New Drug) Application
• Clinical trial management and monitoring

For additional information, please contact:

daishanw@sbcglobal.net

Source: Website: http://www.ExcelRegulatory.com

Source:

Website: http://www.excelregulatory.com

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