Smith Associates, FDA Consultants

Smith Associates, FDA Consultants Consultants Specializing in Regulatory Affairs for FDA Compliance

Our Services
510(k) Submission (Pre-Market Notification)
513g Submissions for Classification Ruling
Pre-IDE Consulting
IDE (Investigational Device Exemption)
PMA/BLA (Pre-Market Approval)
Human Factor Study and Performance Testing
Drug Monograph Registration and Consulting
United States Agent/Official Correspondent Services

Quality System Compliance:
Quality System Part 820 (cGMP) Templates for s

mall and large companies
Quality System Implementation
Quality System Audits

Crisis Management:
483 Responses
Warning Letter Response
Recall Assistance

Address

P. O. Box 4341
Crofton, MD
21114

Website

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