Regulatory requirements for documentation in the pharmaceutical industry have increased significantly in recent years. New research findings, regulatory updates and global coordination mean that dossier management has become increasingly complex. For pharmaceutical companies, this means growing data volumes, more versions and higher demands on traceability, quality and safety.
Advantum Dossier Management Pharma is an efficient and validatable solution for creating, maintaining and archiving product documentation in a CTD (Common Technical Document) structure. The system automates the construction of dossiers, manages variations and sequences for different markets and ensures that the correct versions are always used – making it easier to meet regulatory requirements from EMA, FDA and other authorities.
Efficient document management for regulatory environments
Advantum gives pharmaceutical companies full control of their documentation – from development and clinical trials to regulatory submission and product approval. The system manages the entire document lifecycle and makes it easy to follow up on what has been submitted to different authorities. All correspondence, including responses, decisions and additional documentation, can be stored and linked directly to the correct dossier and product.
Advantum automatically keeps track of the “Current file”, i.e. the document versions that have been approved by the authorities. Thanks to this, you can be sure that the entire organization is always working with the correct version of each document.
CTD (Common Technical Document) & eCTD
The CTD structure is the global standard for submitting drug documentation to regulatory authorities. It is divided into five modules – administrative information, summaries, quality, non-clinical studies and clinical studies. Advantum supports the full CTD format and handles both paper-based and electronic versions (eCTD).
Through automated structure management, users can quickly create new versions, track variations, and build sequences for different markets. This makes it easy to update documentation when changes occur and ensures that all dossiers follow the form and structure required for regulatory submissions.
Flexible management for multiple markets
For companies operating internationally, Advantum makes it easy to manage dossiers for multiple countries. The system handles variations and sequences per market and allows you to view the history of each submission. This way, you can easily track how different versions of the same product have been handled, approved and updated in different jurisdictions.
Features of Advantum Dossier Management Pharma
Advantum Dossier Management Pharma has been proven over many years in demanding environments.
CTD structure and eCTD export
Advantum automatically builds documentation according to CTD structure and prepares for export to eCTD format. This simplifies submissions to authorities and ensures correct structure.
Handling variations and sequences
The system handles variations, updates and sequences for multiple countries. You get a full overview of history, status and submission flows for each market.
Version control and signatures
Each document is automatically versioned and can be electronically signed, ensuring that the correct version is always used and that the process complies with regulatory requirements.
Role-based access and security
Rights are managed via roles and groups, ensuring that only authorized people can create, modify, or approve documents, increasing security and quality assurance.
Regulatory requirements for IT environments
Document management systems for organizations with high demands on information management in regulatory environments. Prepared for validation according to international standards.
Microsoft Office integration
Advantum is a partner with Microsoft, which means that there is full integration with Outlook, Word, Excel and PowerPoint.
Thoroughly tested by leading companies
Advantum Dossier Management Pharma has been developed together with several of Sweden's leading companies and is based on the long experience we have in developing solutions for companies and organizations within Pharma.
FAQ about Dossier Management Pharma
It is a solution for creating, managing and archiving documentation related to pharmaceutical products. The system organizes the information in a CTD structure that complies with international regulatory requirements.
CTD stands for Common Technical Document – a standardized structure for pharmaceutical documentation. eCTD is the electronic version used for digital submissions to authorities.
CTD is used by the EMA in Europe, the FDA in the US and several other regulatory bodies worldwide. It is the global standard for drug documentation.
Thanks to full audit trail and version control, all changes can be tracked, making it easy to demonstrate that processes comply with GxP and regulatory guidelines.
Yes. Advantum supports the entire document lifecycle – from early research and development to regulatory submission and follow-up of approved products.
Life Science and Pharma companies that use Advantum
Frontgrade Gaisler chooses quality-assured DMS
Frontgrade Gaisler, a world leader in embedded computer systems for the aerospace industry, chose Advantum to quality assure its document management. They needed a flexible system that could grow with the business and handle critical information securely.
Moberg Pharma – dossier management within pharma
Moberg Pharma has chosen Advantum Dossier Management Pharma to streamline and quality-assert the entire process from idea to finished product. The system ensures compliance with the industry's strict requirements and provides full traceability.
SenzaGen – document management as a service
SenzaGen uses Advantum as a Service (SaaS) to manage their documentation in a secure, web-based environment with data stored in Sweden. With Advantum, they avoid investing in hardware and gain access to powerful, modern system support.
Niconovum (British American Tobacco) – dossier management
Niconovum has chosen the Advantum Dossier Management Pharma service solution to meet regulatory requirements and streamline document management. The company develops nicotine products under the Zonnic® brand.
BioArctic - new Life Science case
BioArctic, a research-intensive biopharmaceutical company in CNS diseases such as Alzheimer's and Parkinson's, has chosen Advantum as their document and quality management system software. With Advantum, they get a validatable software solution specifically developed for Life Science.
Other well-known customers
In addition to these, AstraZeneca, Orexo, NorthX Biologics and Alligator Bioscience have also chosen Advantum for their DMS and eQMS software needs.
Operation
Advantum can either be installed in your server environment, in the cloud, or you can let us take care of the operation of Advantum in a strictly controlled server environment. Get in touch and we'll help you find the best operating solution!
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