Publishing

Regulatory submissions depend on localized regulations when sending registration files to health authorities for approval. Common formats include: 

– Paper (ePaper)  

– Non eCTD Electronic Submission (NeeS)  

– ASEAN Common Technical Dossier (ACTD) 

– Eurasian Economic Union (EAEU eCTD) 

– Electronic Common Technical Document (eCTD) 

PLG covers all formats. 

This format organizes electronic documents into folders following the Common Technical Dossier (CTD) structure. It contains a general table of contents (TOC) and module-specific TOC. It is quite a rigid structure that does not allow life cycle maintenance. The EU has phased out this method but accepted it in other global regions. Our team provides support in NeeS format for regions where it’s still valid. 

This is another region-specific format for publishing regulatory documents. Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia have specific associated guidelines.  

There are five (5) modules, but it does not follow the CTD structure; though it does have an XML backbone, it does have its own granularity. The PLG publishing team supports this format so clients can directly submit in this region. 

The documents in the dossier are formatted per specific guidelines issued by health authorities to ensure they are eCTD compliant. These documents are then processed by a publishing tool and validated to ensure the final sequence complies with regional specifications. The published sequence is then electronically transferred to health authorities by portals and gateways to facilitate the exchange. This way, the reviewer can receive submissions within moments, negating the need to transport and store paper documents and saving time and money. 

PLG is a submission expert with a proven track record working across different regions, with various formatting, publishing, validation tools, and major submission portals. Our team is experienced with global regulatory applications and has expertise in managing multiple application types. 

With 10+ years of experience, we provide high-quality formatting, publishing, validation, and submission services to pharmaceutical companies. Our publishing platform is part of our Regulatory Operations Department and includes publishers across multiple countries covering Europe, North America, Asia, and Africa. As part of our global operating model, PLG offers up-to-date information about local authorities and regions to which dossiers are submitted to help you navigate all significant markets and regions. 

PLG has two flexible working models that provide high-agility services, including publishing in the client environment using their existing tools or in the PLG environment utilizing our internally validated tools, depending on the client’s needs. 

Dedicated publishers support our clients with heavy workloads; alternatively, we offer a centralized publishing team to handle clients with more sporadic requests. 

Over the last ten years, we have worked with many companies involved with developing new prescription medicines and vaccines, supporting them across the eCTD process.