Products and Services: Pharmaceutical Regulatory Affairs: Preparation of CTA (clinical trail applications), CTAA (clinical trial application amendments), NDS (new drug submissions), SNDS (supplemental new drug submissions), ANDS (abbreviated new drug submissions), post-approval changes (notifiable changes, SNDS), responses to Notices of Deficiency from Health Canada on all of the above, Development and preparation of product monographs. OTC Products: Preparation of DIN (drug identification number) applications, NHP (natural health product) license applications and site-license applications, complete response to IRN (information request notices) for NHP product license/site-license applications. Other Consulting Services: provide input on regulatory strategy for timing and content of submissions, provide input as expert witness in litigations involving patents or other issues related to NOC regulations in Canada.

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Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .Karen Friedman has over 17 years of successful registration experience for pharmaceuticals and natural health products in Canada. After receiving a Master of Science degree from the University of Toronto, Karen has held positions in regulatory affairs for Novopharm, Procter & Gamble and Ferring and has been consulting independently since 2004. Karen Friedman has a Master's of Science degree in Nutritional Sciences and therefore is well-suited for compiling natural health product license applications and site-license applications. Karen Friedman is an active member of Canadian Association of Professional Regulatory Affairs (CAPRA) and Regulatory Affairs Professional Society (RAPS) of the United States.