Consulting / About Dr. Sharlin

Download Dr. Sharlin’s resume as a PDF here.

Download Dr. Sharlin’s resume as a MSWord doc here.

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Summary of Dr. Sharlin’s Consulting Experience

FDA-Related Experience

Having both prepared submissions for many FDA-regulated companies and reviewed submissions as an FDA reviewer, Dr. Sharlin knows both sides of the approval process. He has hands-on experience in the entire approval process for drugs, medical devices and biologics including:

  • Create a regulatory strategy,
  • Write and improve SOPs, protocols, study reports, and annual reports
  • Audit for GCP compliance
  • Design a study,
  • Set up a database,
  • Report on and analyze data,
  • Interpret study results,
  • Prepare FDA submissions.

 

Software Development & Information Technology Experience

Dr, Sharlin has significant hands-on experience in software development and information technology. This includes programming and implementing large database systems. Before working as an FDA reviewer, he was director of customer information systems at a Fortune 250 company. This knowledge has been applied to FDA-regulated companies as follows:

  • Audit companies and systems for compliance with 21 CFR Part 11 (electronic records and electronic signatures),
  • Database design,
  • SAS programming,
  • Improve efficiency and skill of SAS programmers,
  • Validation of software systems (built in-house and purchased).

 

Train Your Staff While Producing Deliverables  

Dr, Sharlin emphasizes applying his teaching skills while doing work. While completing a project he’ll improve the FDA-related knowledge and insight of your staff.