RDC 45/2012 – Stability
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...
Read MoreRDC 21/2013 – Procedures for Granting Patents for Pharmaceutical Products and Processes
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...
Read MoreRDC 20/2013 – Electronic Registration Procedures
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...
Read MoreRDC 27/2012 – Bioanalytical Method Validation
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...
Read More