HCLTech SmPC to PIL Conversion Agents

SmPC to PIL Conversion Agent helps life sciences organizations streamline the creation of Patient Information Leaflet drafts from Summary of Product Characteristics content. The solution is designed for regulatory affairs, labelling, medical writing, and compliance teams that need to convert technical product information into patient-facing content while maintaining alignment with approved source documents and applicable template expectations.

Users can upload or select an SmPC document and generate a structured PIL draft based on the relevant sections, terminology, and approved product information. The agent interprets the SmPC content, transforms technical language into patient-readable text, and organizes the output into the expected PIL structure. The solution can support template-based generation, section-level mapping, readability checks, and review-ready outputs for downstream human validation.

The agentic workflow reduces manual drafting effort by using mapping agents to align SmPC sections with PIL sections, transformation agents to simplify technical language, consistency agents to check alignment with the source content, and review-support agents to highlight areas that may require human attention. Human users remain in control of review, approval, and final document release.

What the customer gets:

• Configured SmPC to PIL conversion agent for regulatory labelling use cases

• SmPC content extraction and section-mapping workflow

• Patient-friendly PIL draft generation based on source product information

• Template-based output structure, where applicable

• Section-level traceability between SmPC inputs and PIL output

• Readability support for patient-facing language

• Consistency checks against source content

• Review-ready draft output for human validation

• Downloadable PIL draft in required document format, where applicable

• User access, security, and governance design considerations

• User walkthrough, handover documentation, and deployment support

Expected business outcomes:

• Reduced manual effort in PIL draft preparation

• Faster conversion of technical product content into patient-facing language

• Improved consistency between SmPC and PIL content

• Better support for labelling review and compliance workflows

• Improved readability and traceability through section-level mapping

• Agentic AI solution design

• Regulatory labelling and patient information content generation

• Life sciences regulatory affairs domain knowledge

• SmPC to PIL section mapping

• Patient-friendly medical content transformation

• Readability and consistency review workflows

• Generative AI document drafting and summarization

• Secure application architecture

• Human-in-the-loop review and governance