Drugs in the making.com
Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. The agency also notes that sponsors can request an exemption from the requirement for individual products, but says it expects companies to provide their "rationale for the exemption as well as an intended plan for converting to eCTD format." [ Read more]
Shruti Bhat, PhD (Tech.), MBA, Certified Lean Six Sigma Black Belt is Continuous Improvement mastermind for Pharmaceuticals & Medical Devices Industry. She is often called "Profitability expert' More about Shruti at http://www.shrutibhat.com/
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Dr. Shruti U. Bhat
Pharmaceutical Manufacturing, Continuous Improvement and Business Transformation Consultant
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