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