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Who is Dr. Joshua Sharlin?

Joshua Sharlin applies his insight about FDA compliance and regulatory affairs (former FDA reviewer), and knowledge about science (PhD in physiology) to analyze and explain regulatory and compliance-related issues involving FDA-regulated companies.

His skills include data integrity and software development which were perfected while working as Director of Hotel Customer Information Systems for Marriott.

Dr. Sharlin is a specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions:

1) What did the company know and when did they know it?

2) What should the company have known and when should they have known it?

3) What should the company have done and when should they have done it?

He began supporting attorneys as an FDA regulatory expert in 2002. His experience includes testifying and being deposed. He currently splits his time as a regulatory affairs consultant (75%) and as an expert witness (25%).

Dr. Sharlin is a strong public speaker and skilled teacher. Over 50,000 people have learned from hundreds of his presentations on over 40 FDA-related technical and regulatory topics. Finally, he consistently writes opinions that strongly support an attorney’s case.