Anselm Assists GOLDEN BIOTECHNOLOGY CORP. in Achieving E-documentation Management and Submission for CTD

As the complexity of drug development and market approval increases, meeting the requirements of various national pharmaceutical regulatory authorities becomes crucial. Leveraging years of experience in guiding the implementation of Oracle Agile PLM in the biotech and medical field, Anselm supports client, GOLDEN BIOTECHNOLOGY CORP., in utilizing Oracle Agile PLM along with Anselm’s developed ‘eCTD Suite’ to implement R&D document management, establish an R&D knowledge platform, and adhere to the Common Technical Document (CTD) framework developed by the International Council for Harmonisation (ICH). This assistance helps GOLDEN BIOTECHNOLOGY CORP. achieve:

 

Compliance with International Standards:

Adherence to international drug review standards such as the U.S. FDA, EU EMA, Taiwan TFDA, Japan PMDA, enhancing efficiency in submissions and obtaining drug certifications.

 

Rapid Generation of CTD Submission Documents:

Capability to generate CTD electronic submission templates based on M1~M5 sections required by different countries. The system efficiently generates CTD electronic submission document lists and data packages from Oracle Agile PLM, saving significant manual effort. Through system checks and assisted report outputs, it reduces the risk of errors, ensures the consistency and compliance of submitted documents, and maintains a complete record of the Serial Number change history.

 

Security and Compliance:

Oracle Agile PLM complies with the requirements of FDA 21 CFR Part 11, ensuring the confidentiality of sensitive data through rigorous permission controls. Additionally, we conduct system verification based on EU GAMP requirements during the implementation process, producing IQ/OQ/PQ documents. Combined with comprehensive R&D process change control, it fully meets the audit requirements of relevant regulations.

 

Real-time Collaboration:

Teams distributed across multiple global locations can achieve real-time collaboration, enhancing the speed of information flow.

 

Flexibility and Scalability:

The system can be adjusted according to client needs, providing scalability to address future technological and regulatory changes.

 

We understand the rigor and complexity of drug review processes. Through our solution, we offer a reliable, efficient, and compliant solution for the biopharmaceutical industry (new drugs, active pharmaceutical ingredients, generics), facilitating smooth regulatory approvals and rapid market entry worldwide. We look forward to providing optimal support for your business and jointly facing the challenges of the global biopharmaceutical industry.