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Additions to SpeedUpFDA.com

Overview 10Sep09, FDA-Internet 22Sep09, Internal FDA Standards 24Sep09, AE Reporting for Drugs & Biologics 8Oct09, AE Reporting for Devices

Overview Building better FDA submissions--

Mission Statement Seven Benefits when Hiring Dr. Sharlin Training Experience Resume

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

View This Month's Training Classes Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

In Progress

Solve Regulatory Problems – Consulting Services
Description	Advantages of Hiring Dr. Sharlin	Classes I Developed So Others Can Learn From My Experience ⁽¹⁾
Analyzing regulatory problems and explaining their solutions arising from questions posed by FDA reviewers or issues that originate from the design, execution or analysis of clinical trials and clinical data.	Because I have worked on both sides of the regulatory fence having both created and reviewed submissions, I understand how reviewers think and work. For me, FDA actions and reactions are predictable.	“What Needs To Be in a Product Submission – An FDA Reviewer’s Perspective”. The class explains how reviewers think and work. “Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review” “Good Review Management: FDA’s Internal Standards and Expectations of Industry”
⁽¹⁾ Contact me and the table of contents from any class can be emailed to you