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Prior to joining Octagon, Ms. Smerkanich has been in various positions within Regulatory Affairs Departments and most recently consulting for nearly 20 years. She spent 10 years with Merck before becoming a consultant.
She has prepared and maintained IND applications for over 30 compounds and prepared multiple New Drug Applications, background packages, safety update reports, Summary Basis of Approval documents, efficacy and labeling supplements, annual NDA and periodic ADR reports for submission to regulatory authorities. She is trained and experienced in preparing Electronic Submissions. She has also written Standard Operating Procedures for many of the leading pharmaceutical companies. She has served as Regulatory Liaison with FDA/CBER and the Orphan Drug Product Office. She has directed preparations for FDA meetings and has provided technical expertise for numerous NDA filings. Ms. Smerkanich has also directed activities relating to Quality Assurance Audits and participated in training activities for in-house personnel and industry leaders.
Ms. Smerkanich holds a Bachelor of Science Degree in MicroBiology and a Bachelor of Arts in Russian from the University of Connecticut. | 