Services
Driving Intelligent Transformation for Pharmaceutical CDMOs, Built on Trust
Solution
AI Agent Solutions for End-to-End Pharmaceutical Intelligence
therapiAI provides AI Agent solutions spanning R&D, manufacturing, quality, and operations—
enabling pharmaceutical CDMOs to accelerate digital transformation with higher efficiency, lower risk, and a clear path toward intelligent manufacturing
GMP AI Agent
Streamlines complex GMP compliance documentation workflows.
From regulatory interpretation to document comparison, it enables QA, RA, and engineers to complete high-accuracy compliance tasks more efficiently, significantly reducing review and documentation time while improving overall quality consistency.
Regulatory guidance
Regulatory document interpretation with rapid impact highlighting.
As regulatory updates accelerate, teams often spend extensive time checking the impact line by line.
The GMP AI Agent interprets FDA, EMA, and ICH documents and quickly marks impacts on SOPs, batch records, or processes, eliminating the need for RA to search through hundreds of pages.
The GMP AI Agent interprets FDA, EMA, and ICH documents and quickly marks impacts on SOPs, batch records, or processes, eliminating the need for RA to search through hundreds of pages.
Document analysis
Effectively reduces review fatigue and the risk of overlooking details.
Large volumes of GMP documents (MBR/PBR, COA, deviation reports) can easily lead to missed details when reviewed manually.
AI reads documents at scale, identifies key information, highlights missing fields or abnormal entries, and provides summarized compliance highlights.
The GMP AI Agent interprets FDA, EMA, and ICH documents and quickly marks impacts on SOPs, batch records, or processes, eliminating the need for RA to search through hundreds of pages.
Document comparison
AI compares document versions and generates audit-ready change lists.
Version control is one of the most time-consuming and error-prone GMP tasks.
AI compares different versions of SOPs and protocols, highlights all modifications, adjustments, and deletions, and generates change logs ready for audits.
Automatic typo correction
Accurately fixes typos and formatting to ensure language compliance.
GMP documents require precise and consistent terminology, units, and formatting. Manual proofreading is time-consuming and prone to repeated oversight.
AI performs typo correction and formatting adjustments to ensure documents meet compliance standards.
One-Click document format conversion
Significantly reduces repetitive formatting work in tech-transfer or partnership projects.
External documents from customers, suppliers, or partners often do not match internal templates and require manual reformatting.
AI converts external documents into versions compliant with internal specifications, including tables, images, paragraphs, and annotations, while preserving change history.
Proposal writing
AI-generated drafts accelerate proposal creation.
Whether for audit responses, technical proposals, or compliance explanations, documents must remain professional and regulation-aligned.
AI generates draft documents based on client requirements, internal templates, and past compliance cases, shortening the initial writing cycle.
Report generation
Reduces data consolidation time from days to hours.
Annual reviews, equipment inspections, and deviation analyses require extensive data collection and reformatting.
AI extracts information from multiple data sources and compiles it into annual reports, quality reviews, or equipment inspection reports using standard templates.
Worksheet generation
Quickly generates ready-to-use forms for new batches, tech-transfer tasks, or client requests.
For complex GMP forms, standardized generation ensures accuracy and compliance while reducing manual workload and human error.
AI generates forms based on predefined templates, including correct fields, standardized wording, and consistent formatting.
BioFusion Analytics AI Agent
Transforms imaging and process data into actionable early-stage predictive insights through multimodal AI.
It helps teams select the right cell lines faster, predict yields, monitor quality trends, and shorten development timelines—enhancing confidence in every process decision.
Cell line selection
Choosing the right cell line early improves success rates and significantly shortens the downstream development cycle.
Traditional selection relies on experience and repeated experiments, often overlooking high-potential clones.
BioFusion AI builds prediction models using imaging and process data to evaluate growth performance early and generate ranking lists, reducing lengthy screening cycles.
Cell yield prediction
Makes yield risks visible early, shifting from reactive testing to proactive prediction.
Cell yield is affected by feeding strategy, batch variability, and operator behavior.
AI builds early-stage prediction models using imaging features and batch data to identify low-yield risks before scale-up.
Cell quality identification
Uses AI to help determine cell condition without relying solely on visual or experience-based judgment.
Morphology, differentiation ratio, and cell health significantly affect final quality, and manual evaluation is subjective and time-consuming.
BioFusion AI analyzes cell images to identify unstable cell subpopulations, supporting consistency from the earliest stages.
Protein amount prediction
Predicts production trends to ensure high-yield processes.
AI analyzes historical batch growth curves, metabolic data, and culture parameters to forecast future yield trends and support high-productivity outcomes.
Harvest time prediction
Accurately determines the optimal harvest point to avoid quality or yield loss.
Different batches and cell lines have unique growth curves and accumulation rates.
BioFusion AI analyzes growth trends and predicts the optimal harvest timing to prevent losses caused by harvesting too early or too late.
Transcriber AI Agent
Converts every meeting, interview, and discussion into structured knowledge within seconds.
From speech-to-text conversion to automatic summarization, it turns time-consuming documentation into efficient information extraction, accelerating cross-department collaboration.
Speech-to-Text
Meeting minutes no longer require handwriting, replaying recordings, or manual transcription.
Transcriber AI converts meeting, interview, or discussion audio into editable text, reducing transcription errors and cleanup time.
Teams can quickly turn discussions into documents, tasks, and follow-up workflows.
Transcripts summary
Condenses lengthy discussions into actionable insights.
AI identifies key points, decisions, and action items and organizes them into clear summaries.
Whether cross-team sync meetings or client discussions, summaries are generated quickly and improve communication efficiency.
Tutor AI Agent
An intelligent training assistant that supports Q&A, assessment generation, and training record creation around the clock.
It streamlines complex training workflows, enabling faster knowledge transfer, more consistent training quality, and easier audit preparation.
24/7 intelligent guidance and Q&A
A digital training assistant that supports continuous knowledge delivery.
Tutor AI helps new employees onboard faster, reduces repetitive guidance from senior staff, and preserves organizational knowledge.
Automatic generation and scoring of assessment content
Standardizes and tracks training and qualification processes.
Tutor AI selects suitable questions from a test bank based on departmental training needs, helping maintain consistent training quality and ensuring competency requirements are met.
Automatic generation of standardized training records
Prevents gaps or inconsistencies in manual training logs and simplifies audits.
AI generates training records based on training status, test results, and course content, applying standardized templates for HR and supervisors to track progress easily.
Service Process
Service Process
POC Agreement Signing (Including NDA)
- The two parties sign a POC agreement that includes a Non-Disclosure Agreement (NDA).
- Defines confidentiality responsibilities
- Establishes the starting point of the collaboration
Needs Assessment Meeting
- The client presents its current processes, challenges, and expected outcomes.
- therapiAI reviews data quality and application potential, proposing feasible approaches
- Both parties align on objectives and form a preliminary project consensus
A test-version AI Agent is built using the client’s data for validation.
- therapiAI develops an initial model based on provided datasets
- Technical teams jointly evaluate the model’s outputs
- POC is considered successful once predefined performance criteria are met
Contract Signing
- A formal contract is signed based on POC outcomes.
- Statement of Work (SOW) is drafted to define responsibilities and deliverables
- Official collaboration begins and preparation for deployment and customization starts
Platform Deployment
- The core platform is deployed and integrated into the client’s environment.
- System integration of user access, data pipelines, and platform interfaces
- Initial training and platform acceptance testing are conducted
Customized AI Agent Delivery
- Client-specific AI Agents are developed and delivered.
- Custom AI Agents built according to defined requirements, Data optimization performed to ensure accuracy and regulatory consistency
- Final validation completed with documentation and maintenance plans delivered
Long-term technical and operational support is provided.
- Continuous monitoring and system health checks
- Supports the client’s ongoing AI transformation and process optimization
- Expert consultation and iterative improvements
FAQ
FAQ
What types of companies does therapiAI primarily work with?
A: Our main clients are medium to large pharmaceutical companies and CDMOs with stable production lines and regulatory requirements.
Flexible collaboration plans are available for companies of different scales.
therapiAI adopts a subscription-based model, supporting both long-term enterprise deployment and flexible onboarding for new clients.
For details, please contact our team.
Clients report shorter R&D cycles, reduced trial-and-error costs, faster document review, improved BD performance, and higher delivery efficiency.
Yes. therapiAI provides API and on-premise integration services, connecting with systems such as LIMS, ERP, and GMP document management platforms to ensure secure and efficient workflows.
Interested in Implementing an AI Agent Platform?
Contact us to explore how therapiAI can be your partner in advancing intelligent pharmaceutical manufacturing.