Summary: Dr. Sharlin has practical hands-on experience in many aspects of drug and
device development including; protocol development, regulatory affairs, design and
execution of studies, data collection, data management, data reporting, data security,
statistical analysis, software audits, software validation, technical writing, and finally FDA compliance and FDA evaluation for safety and efficacy. Expert in GCP regulations.

Highlights of Qualifications & Services
* FDA drug reviewer and FDA statistician.
* Solve GCP compliance deficiency problems.
* Developed solutions so patient registries met FDA compliance expectations .
* Developed risk assessment procedures for data collection and information analysis.
* Design databases for clinical trial information repositories
* Expert in design, execution & statistical analysis of clinical trials for drugs & devices
* Authority in 21 CFR Part 11 compliance and assessments
* Specialist in validation of computer systems
* Auditor of data management departments, CROs and software vendors
* Expert in developing strategies for reducing FDA approval time
* Technical writer, have written SOPs, documentation, study reports, etc.
* Taught validation, software development, Part 11 compliance and regulatory affairs to
thousands of people from hundreds of pharmaceutical and medical device companies