Auto Document-Level Publishing - Overview
Auto Document-Level Publishing leverages advanced automation technologies to facilitate Regulatory document creation, formatting, and submission. By automating repetitive tasks such as document conversion, hyperlinking, and quality checks, this service minimizes manual intervention, thereby reducing the risk of human error and expediting the overall publishing process.
The service encompasses:
- Document Processing: Automated conversion of documents from various formats to compliant PDFs, ensuring all necessary properties and metadata are correctly applied.
- Submission Automation: Streamlined assignment of documents to the appropriate eCTD sections, including the generation of leaf titles and file names based on predefined criteria.
- Quality Control: Implementing automated quality checks to ensure compliance with Regulatory standards significantly reduces the time spent on manual reviews.
Auto Document-Level Publishing
Freyr Solutions brings extensive expertise in Regulatory Operations, with a proven track record in publishing automation. Our team comprises specialists in Regulatory Affairs, document management, and automation technologies. Key areas of expertise include:
- In-depth understanding of global Regulatory requirements and standards, ensuring that all automated processes meet necessary compliance benchmarks
- Proficiency in deploying Robotic Process Automation (RPA), Machine Learning (ML), and Natural Language Processing (NLP) to enhance operational efficiency
- Experience across various sectors, including Biologics, Medical Devices, and Pharmaceuticals, allowing us to tailor solutions to meet specific client needs
The Auto Document Level Publishing service offers numerous advantages for organizations looking to optimize their Regulatory publishing processes:
- Automation of routine tasks accelerates the publishing timeline, enabling faster submission of documents to Regulatory agencies
- Enhanced Accuracy by minimizing manual input, the service significantly reduces the likelihood of errors in document preparation and submission
- Streamlined processes leading to reduced labor costs and resource allocation, allowing organizations to focus on strategic initiatives rather than administrative tasks
- Adaptation of varying submission volumes, making it suitable for organizations of all sizes, from small biotech firms to large multinational corporations
- Automated quality checks and adherence to Regulatory standards ensure that all submissions are compliant, reducing the risk of rejections or delays
