Next Gen Analytical Data Flow Interface

The US FDA is progressively embracing artificial intelligence (AI) and structured data systems to modernize its drug review processes. Through initiatives like PQ/CMC (Pharmaceutical Quality/Chemistry, Manufacturing, and Controls) and KASA (Knowledge-Aided Assessment and Structured Application), the agency aims to transition from traditional, narrative-based submissions to structured, data-driven formats. Together, these initiatives promise to improve review efficiency, consistency, and transparency in regulatory decision-making.

As the pharmaceutical industry prepares for the upcoming regulatory submission standards, Evotec is at the forefront of enabling a seamless transition to structured, digital data submission with our innovative solution Next Generation Analytical Data Flow Interface - NxADFI.

Evotec’s Next Gen Analytical Data Flow Interface (NxADFI) platform is a cornerstone of our digital transformation strategy, aligning with the FDA’s PQ/CMC project and HL7 FHIR standards. It enables:

• Regulatory Readiness: NxADFI supports structured data outputs (JSON, XML, FHIR-compliant APIs), ensuring compatibility with evolving global regulatory requirements. No more manual data transfer, transcription check. Your data trending is just a click apart!
• Data Integrity and Traceability: Automated data transfer eliminates transcription errors, maintains full audit trails, and ensures end-to-end traceability across the sample lifecycle.
• Data Security: Evotec NxADFI interface is a secure mode of data transfer. Each file generated creates logs in immutable vaults and a secure key only intended client have access. Sender identity is verified before uploading, ensuring authenticity and preventing unauthorized access.
• Confidentiality: Our system is built with confidentiality at its core. Each client and study are uniquely tagged at the outset, ensuring complete segregation throughout the data lifecycle - from setup to generation. This design guarantees that sensitive information remains isolated, secure, and fully traceable.
• Operational Efficiency: By automating data exchange between instruments (e.g., balances, pH meters), Empower®, and ERP/MES/QMS systems, NxADFI significantly reduces manual workload and accelerates decision-making.
• Scalability and Flexibility: Whether our clients need XML, JSON, or FHIR outputs, NxADFI adapts to the preferred format and integrates seamlessly with the client’s existing infrastructure.
• Real-Time Insights: Agile data assessment capabilities (Algorithms, AI) enable faster, more informed decisions, supporting proactive quality control and stability management.

Are you preparing your data repository for the shift to structured, digital submissions? Evotec can support you from the earliest stages of design, helping integrate Module 3 stability data directly into your systems. Our in-house experienced IT experts work closely with your team to establish robust interfaces, while our computer system validation specialists ensure full GMP compliance.

We’re well equipped to support large-scale, late-phase stability studies with the flexibility to grow alongside your needs. With state-of-the-art quality control laboratories and a team of expert scientists, Evotec is well-equipped to support your structured submission needs - efficiently, compliantly, and at scale.

From sample login and planning to testing, reporting, and inventory management, NxADFI powers a fully paperless, automated Labware LIMS environment, our PharmaLIMS. Key features include:

• Automatic generation of stability reports and Certificates of Analysis (CoAs)
• Integrated OOS/OOT investigation workflows
• Electronic approvals with e-signatures and audit trails
• Full compatibility with mobile and tablet devices for remote access

PQ/CMC focuses on standardizing electronic submissions using formats like HL7 FHIR, enabling automated data integration into FDA systems. KASA complements this by leveraging AI and structured data to perform risk-based assessments, automate analyses, and enhance lifecycle knowledge management.

Our Next Gen Analytical Data Flow Interface and PharmaLIMS provide a seamless digital solution for regulatory readiness, quality, and speed. 

Our expertise in analytical development and digital innovation ensures that the transition to PQ/CMC compliance is not only smooth but strategically advantageous. Unstructured formats will be soon obsolete—and non-compliance to the new PQ/CMC will mean rejection. 

By adopting Evotec's NxADFI, our clients gain a future-proof solution that enhances data quality, accelerates regulatory timelines, and ultimately helps bring medicines to patients faster.