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RDC 45/2012 – Stability

Posted by on Sep 9, 2014 in Bioanalytical Translations, Uncategorized | 0 comments

RDC 45/2012 – Stability Provides guidance for conducting stability studies of active pharmaceutical ingredients.   RDC 45/2012, August 2012 (Complete English Translation)        Terms of Use Translators:  Juliane Carvalho and Donald L Reynolds, PhD   RESOLUÇÃO – RDC Nº 45, DE 10 DE AGOSTO DE 2012 (Original ANVISA Source...

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RDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes

Posted by on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes Changes Resolution – RDC # 45 of 23 June 2008, which establishes the administrative procedure concerning the prior approval of ANVISA for the grant of patents for pharmaceutical products and processes.   RDC 21/2013 (Complete English Translation)        Terms of Use Translators:  Juliane Carvalho and Donald L Reynolds, PhD   RESOLUÇÃO -RDC Nº 21, DE 10 DE ABRIL DE 2013 (Original ANVISA Source...

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RDC 20/2013 – Electronic Registration Procedures

Posted by on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 20/2013 – Electronic Registration Procedures Regulates the procedures for the electronic registration of new medications.   RDC 20/2013 (Complete English Translation)        Terms of Use Translators:  Juliane Carvalho and Donald L Reynolds, PhD   RESOLUÇÃO – RDC Nº 20, DE 10 DE ABRIL DE 2013 (Original ANVISA Source...

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RDC 27/2012 – Bioanalytical Method Validation

Posted by on May 30, 2013 in Bioanalytical Translations | 0 comments

RDC 27/2012 – Bioanalytical Method Validation Provides the minimum requirements for the validation of bioanalytical methods used in studies for the registration and post-registration of medicines.   RDC 27/2012, May 2012 (Complete English Translation)        Terms of Use Translators:  Juliane Carvalho and Donald L Reynolds, PhD   RESOLUÇÃO – RDC Nº 27, DE 17 DE MAIO DE 2012 (Original ANVISA Source...

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