This site uses cookies to improve your experience. By viewing our content, you are accepting the use of cookies. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country we will assume you are from the United States. View our privacy policy and terms of use.

Remove Communication Remove Method Validation Related Topics
Process Improvement Packaging Documentation Compounding Dosage Pharmaceutical Companies FDA Vaccines Pharmaceutical Companies More Related Topics >
article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.

Documentation 52
Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52
article thumbnail

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies.

Documentation 52
Documentation FDA Communication Packaging 52
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

 

Stay Connected

Join 5,000+ Insiders by signing up for our newsletter

About
Webinars
About
Editions
Webinars
Editions
Topics
Powered by Aggregage | Terms and Conditions | Your California Rights and Privacy Policy
© Aggregage 2024