“Milestone supported our organization’s recent pre-IND meeting with FDA. Che proved to be an invaluable asset in advising our team and compiling/submitting our FDA meeting request letter and meeting briefing package (and handling all correspondence with FDA as our designated regulatory representative). All project deliverables were submitted on-time, with the utmost attention to detail, and under budget.”

“I’ve had the pleasure of knowing and working with Che for several years while we were both employed by the Johns Hopkins School of Medicine. This collaboration has continued even as our career paths took separate directions. I’ve often referred to Che as “my walking-talking-manual-friend.” Warm and approachable, never punitive, Che always offered excellent feedback and guidance in a collaborative capacity. He possesses a wealth of knowledge with an uncommon ability to explain complex and sometimes confusing regulations in a way that’s easy to remember and explain to others.

More recently, Northside Hospital invited Che for a 2-day consult visit in order to speak on several GCP-related topics and work with my colleagues on various quality assurance process improvement initiatives. His unbiased 3rd party thoughts were well-received and sincerely appreciated.”

“Che came for several days to our facility with a wealth of knowledge. His recommendations to streamline and improve our quality management and assurance processes and to assure adherence to regulatory guidelines will help our fast-growing operations. Che is very responsive and passionate about his work and we look forward to his continuing guidance. I can highly recommend Che to anyone who needs outside expertise in the field of regulatory compliance.”

“Che has served as my dedicated regulatory submission agent on my multi-protocol Sponsor-Investigator IND for several years now and has done so with the utmost professionalism, reliability, and efficiency. What’s more, whenever I have had questions on various regulatory requirements or strategies, he has always provided clear and concise advice and input.”

“I audited and monitored several government-funded studies at Johns Hopkins Sidney Kimmel Comprehensive Canter Center (SKCCC) during Che’s nearly six years as their QA Manager. I invariably found his QA team and his research colleagues prepared, compliant, and responsive at every review.”

“Che provided excellent independent monitoring of several IND studies that I worked on as Research Program Manager at Johns Hopkins School of Medicine. In addition, he was very helpful when IND-related questions arose regarding these studies. I learned a lot working with Che on these projects!”

“Che is a diligent worker with a passion for learning. He continuously strives for improvement, always looking for ways to better understand an issue or find ways to attack problems in a different way. He devotes considerable time to understanding the world around him and has an intellectual command of a wide variety of global issues. ”

“I’ve had the privilege to know and work with Che for over 8 years. His knowledge and experience working with the highest level of regulatory issues is second to none. I have worked with Che on monitoring and auditing, comprehensive SOP creation, Food and Drug Administration dealings, and complex compliance situations. Beyond his acumen and expertise, he is humble and compassionate, dedicated to the highest moral standing, and fiercely loyal to his customers. I recommend Milestone Regulatory Experts to anyone looking for an expert in the critical field of regulatory compliance.”