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Accelerating FDA and EMA filings through structured data, traceability, and submission ready content
Regulatory submissions demand precision, traceability, and consistency across massive volumes of scientific data. From stability studies to batch release testing, every dataset must be accurate, complete, and inspection ready.
Many organizations still assemble submissions by reconciling spreadsheets, emails, instrument outputs, and disconnected systems. A unified LIMS and ELN platform transforms this process. By structuring data at the point of generation, SciCord can enable teams to prepare regulatory content faster, reduce risk, and submit with confidence.
Whether preparing a submission for FDA or EMA review, organizations follow a structured pathway. Even when product type and region vary, the core stages below reflect common regulatory expectations.
| Stage | Key Activities |
| Development and data generation | Conduct analytical validation, stability studies, and batch testing while compiling supporting laboratory documentation for quality review. |
| Data verification and quality review | Perform QA assessment, reconcile deviations, confirm specifications, and ensure completeness and consistency of laboratory records. |
| CTD module preparation | Organize validated data into required modules including quality summaries, manufacturing details, and supporting analytical data tables. |
| Submission and agency interaction | Submit dossier electronically, manage regulatory correspondence, and provide clarifications or additional information during agency review. |
Stability protocols, pull schedules, and test results are captured in a standardized format, allowing automated generation of stability data tables suitable for inclusion in Common Technical Document quality sections without manual reconciliation.
Batch records, specifications, and certificate of analysis results are linked directly to test outcomes, enabling rapid creation of batch analysis summaries that align with regulatory expectations for traceability and completeness.
Comprehensive audit logging provides defensible traceability for every data point, calculation, and approval step to simplify inspection readiness and support rapid responses to incoming regulatory queries.
Regulatory success depends on both scientific rigor and operational discipline. A unified informatics platform strengthens both dimensions simultaneously.
Digital transformation in regulatory management is not theoretical. Organizations adopting SciCord have demonstrated measurable gains in speed, accuracy, and compliance maturity.
This case study below demonstrates how a SciCord customer achieved regulatory approval and improved overall compliance. Key wins and impact areas include:
– U.S. Food and Drug Administration, Data Integrity and Compliance With Drug CGMP Guidance
Regulators expect not only accurate data, but controlled, attributable, and traceable records. By embedding compliance into everyday laboratory operations, SciCord can support regulatory teams delivering submissions from a foundation of structured, inspection ready data.
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Senior Pharmaceutical Scientist
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