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At the very first time, if any company is planning to apply for an IND and start planning internally, it starts with the a basic target...

As you may know, pharmaceutical products are highly regulated. However, the different regulatory requirements in various regions impose...

Regulatory variations refer to changes made to the marketing authorization of a medicinal product after it has been approved for its use....

Clinical trials play a crucial role in advancing medical research and improving patient care. Within the European Union (EU), there are...

List of links giving access to the most relevant variation guidance published by FDA

At the very first time, if any company is planning to apply for an IND and start planning internally, it starts with the a basic target...

CMC, or Chemistry, Manufacturing and Control are activities needed to ensure overall pharmaceutical product quality.

Knowledge Center is including ideas, opinions and recommendations on how to handle your RA CMC activities

Background on the approach for referencing excipients in compliance with an USP or NF monograph

Current EU Variations Regulations

Recommendation on HMA Article 5 on unforeseen variations

List of useful CMC guidance published by SUPAC

Current EU Variations Regulations

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

EU Variations General Information

Useful links to search for FDA Guidance

NDA requirements update in 2020

Registration Testing · When registration testing is needed: · NDA of NCE/NBE · Post-approval CMC changes: case by case,...

Guideline on Minor Variation Applications for Biologics - April 2022

Brazil- Biologics Regulations and Guidelines