Synapse Fusion · Pharmaceuticals
Faster documents, the same GxP discipline.
Pharmaceutical companies and distributors live on documents: submissions, safety reports, procedures, enquiries and tenders. AI can draft, extract and summarise much of that work, while qualified people review and approve. The result is time back for expert judgement, without loosening the controls regulators expect.
Where the time goes
Where expert time goes today
Highly qualified people spend a large part of their week on documents that must be exact, traceable and on time.
Regulatory dossiers and variations
Submissions, variations and responses to agency questions involve long documents that must stay consistent across many sections and markets.
Safety case volumes
Pharmacovigilance teams receive adverse event reports from many channels, each to be entered, checked and reported within strict timelines.
Procedures and quality records
SOPs, deviations, change controls and CAPA reports take time to write, review and trend.
Enquiries, tenders and customers
Medical information requests, hospital tenders and distributor queries each need accurate answers drawn from approved content.
What AI can take on
Six places to start.
In every case, AI prepares and a person checks and decides. The value comes from your people knowing where to use it, and measuring what it gives back.
TodaySpecialists draft sections, cross-check figures between documents and summarise agency questions by hand.
With AIAI drafts from approved source documents, flags inconsistencies between sections and summarises agency correspondence. Regulatory staff verify and sign off every word.
Faster preparation and fewer late inconsistencies.
TodaySafety staff read incoming emails, forms and articles and type the key details into the safety database.
With AIAI can extract the key case details into a draft entry and help sort literature hits by relevance. Safety professionals check every case and make every assessment.
More time for medical review and less risk of missed timelines.
TodayMedical information teams search approved documents and write each reply to a healthcare professional individually.
With AIAI drafts a reply from your approved standard responses and references. A qualified reviewer edits and approves before it is sent.
Quicker, more consistent answers to healthcare professionals.
TodayQuality teams write and revise SOPs and read through deviation and CAPA records to spot recurring issues.
With AIAI drafts procedure updates and summarises records to show recurring themes, outside any critical GMP decision. Quality staff review, approve and decide on actions in your validated systems.
Shorter review cycles and earlier sight of recurring problems.
TodayTeams assemble tender responses and answer pharmacy and hospital queries from scattered documents.
With AIAI assembles first drafts from your approved product and company information and answers routine queries for staff to check. People review prices, claims and commitments.
More tenders answered well and faster replies to customers.
TodayTrainers build course material, quizzes and onboarding packs by hand for each procedure change.
With AIAI drafts training summaries, questions and onboarding material from current procedures. Trainers and quality approve the final content.
Training ready sooner when procedures change.
Rules that apply
Inside the rules you already work to
AI is used within your existing GxP, data integrity and safety framework, with every use agreed with quality, IT and regulatory leads first.
- GxP and EU GMP Annex 11. Records that count for GxP stay in validated systems under Annex 11, which remains the version in force. A revised Annex 11 and a new Annex 22 on AI were consulted on in 2025; Annex 22 is still a draft, and its treatment of generative AI in critical GMP uses is under review.
- FDA expectations. FDA’s January 2025 draft guidance sets out a risk-based way to show an AI model is credible when it produces information supporting regulatory decisions on drugs and biologics. It is still a draft, and the company remains responsible for what it submits.
- Safety and personal data. Adverse event and medical information data includes health data, a special category under the GDPR. Qualified people stay in charge of every safety assessment, report and reply.
A sensible start
Small, measured, owned by your people.
- 1
Start outside critical GMP decisions
Choose document-heavy work such as medical information drafts, training material or tender preparation, where a person reviews every output.
- 2
Agree what to measure
Record today’s time per document or case so the time handed back can be shown to quality and finance.
- 3
Train people on their real work
Show each team how to use the approved tools on their own documents, and how to check and record what the AI produced.
Questions
What people in pharmaceuticals ask first.
Does using AI mean we have to revalidate our systems?
Not for every use. Drafting and summarising outside GxP records usually sits outside validated systems, while anything that creates or changes a GxP record needs your normal computerised system controls. Your quality team decides where the line falls.
Can AI take on pharmacovigilance case processing?
It can help with parts of it, such as extracting details and sorting literature, but qualified safety staff check every case and make every assessment. Reporting obligations stay with the company.
What does the EU AI Act mean for us?
Everyday document work is usually not a high-risk use, but the AI Act duty to support staff AI literacy applies already. AI built into products such as medical devices that need third-party conformity assessment follows the high-risk rules, on the timetable as amended in 2026.
Explore another view
Sources: European Medicines Agency, 2025 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission (1,765,581 ICSRs collected and managed in 2025) · European Commission, EudraLex Volume 4, EU GMP guidelines (Annex 11 Computerised Systems, January 2011; no Annex 22 listed) · PIC/S, Joint stakeholders consultation on the revision of Chapter 4, Annex 11 and new Annex 22 (7 July to 7 October 2025) · European Medicines Agency, GMP multistakeholder workshop on expert contributions to AI guidance development (Annex 22), 30 June to 1 July 2026 · US FDA, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft guidance, January 2025) · Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the AI Act: Article 4 and Article 113 dates
Your move
You’re already paying for AI. Let’s make it pay you back.
Start with a conversation. Tell us what concerns you about AI in your organisation. We will listen, answer with practical solutions and propose a path forward that fits. Or write to jacques@synapse-photonics.com.
