SPL/SPM (Creation & Updation) - Overview
SPL and SPM are critical components of the pharmaceutical labeling process. SPL is an XML-based format used for the electronic submission of product information to Regulatory authorities, while SPM serves as a centralized repository for product data.
Our SPL/SPM services encompass the entire lifecycle of product labeling, from initial creation through to updates and maintenance. This includes managing changes due to regulatory updates, safety information, and product modifications. By leveraging advanced technologies and regulatory intelligence, we ensure that your labeling documents are not only compliant but also aligned with industry best practices, thus minimizing the risk of regulatory issues and enhancing the clarity and consistency of your product information.
SPL/SPM (Creation & Updation)
- Extensive understanding of global Regulatory requirements for SPL/SPM
- Expertise in utilizing advanced software tools for creating and updating SPL/SPM documents
- Attention to detail ensuring accuracy and compliance in every document
- Collaboration among Regulatory, medical, and technical experts to produce comprehensive labeling documents
- Extensive experience with eCTD and non-eCTD formats
- Ensures compliance with FDA, EMA, and other global Regulatory standards
- Maintains consistency and accuracy in product information across all markets
- Streamlines the labeling process, reducing time and costs associated with updates
- Enhances the quality and clarity of information available to healthcare providers and patients, promoting better patient outcomes
- Efficient handling of Regulatory queries and submissions
