Guidance GUI-0064 - Canada's Drug & Health Product Regulatory Experts

16 November 2016

Health Canada announces the issuance of a new Guidance GUI-0064: How Health Canada inspects medical device establishments. These guidelines will help anyone with a medical device establishment licence, understand and prepare for an inspection as well as to ensure that they are carried out in a consistent manner. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/md-im/md_insp_prog-prog_insp_mm-eng.pdf

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With over 20 years of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Après plus de 20 ans de résultats et de succès constants, SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.