We build AI for Canadian drug manufacturers, biotechs, CROs and distributors that drafts regulatory documents, reads adverse event reports and reviews deviations, delivered with the validation file your quality unit expects.
AI for pharma and life sciences in Canada is used widely in discovery and clinical analytics, but far less in the regulated operations that consume most of the headcount: quality, regulatory affairs, pharmacovigilance and medical information. Those teams handle large volumes of structured writing and review, which is exactly what current language models do well.
What holds them back is validation. Any computerized system that touches GMP, GCP or pharmacovigilance records must be fit for its intended use, and a model that changes behaviour without control is a finding waiting to happen. The answer is to treat AI like any other GxP system: defined intended use, risk-based validation, change control and a person who signs.
Regulatory writers assemble module summaries, product monographs and responses to questions from dozens of source reports, version by version.
Reports come from call centres, patient support programs, email and literature, and each one must be triaged and assessed against a strict reporting clock.
Investigations stall because finding similar past deviations, root causes and batch records means searching several systems by hand.
Quality leaders are open to AI but unsure how to validate a model that is not deterministic, so promising tools stay in pilot.
First drafts of summaries, monograph sections and responses to Health Canada questions are assembled from your approved source documents, with every statement traced to its reference.
Writers review and refine a traced draft instead of starting from scratch
Delivered by AI features in your productIncoming reports are read, checked for the minimum criteria for a valid case, coded and pre-populated in your safety database, with seriousness flagged for a pharmacovigilance specialist.
Specialists assess cases instead of transcribing them
Delivered by Document processingFor each new deviation, the assistant retrieves similar past events, their root causes and the CAPAs that worked, and drafts the investigation outline for the quality owner.
Investigations start from your own history, not a blank form
Delivered by AI assistants on your company knowledgeOperators and QA staff ask questions about current SOPs and master batch records and get answers from the effective version only, with the section cited.
Answers always come from the effective SOP, never a superseded copy
Delivered by AI assistants on your company knowledgeProduct demand, batch yields and inventory forecast by SKU and market, so planning and procurement see shortages before they happen.
Supply risks show up in the plan, not in a backorder
Delivered by Forecasting and analyticsValidated interfaces between your quality, regulatory and safety systems and the AI tools, with audit trails that meet data integrity expectations.
One record of truth across quality, regulatory and safety
Delivered by Systems integration and automationIn regulated life sciences work, the question is not whether AI is accurate on average but whether it is fit for its intended use and under control. We deliver AI with the intended-use statement, risk assessment, test evidence and change control your quality unit needs to approve it. We do not certify or guarantee compliance; your quality unit remains the approver.
Computerized systems used in GMP activities must be validated, access-controlled and audit-trailed. We design AI components to Annex 11 expectations, including data integrity and controlled changes.
We follow a risk-based approach in line with ISPE GAMP 5 (second edition): intended use, critical thinking about risk, and test effort scaled to impact, with model and prompt versions under change control.
Under section C.01.017 of the Food and Drug Regulations, serious adverse drug reactions must be reported to Health Canada within 15 days. AI speeds intake and triage; a qualified person confirms every assessment and submission.
Where AI touches trial documents or data, Part C, Division 5 of the Food and Drug Regulations and ICH good clinical practice apply. We keep source data untouched and every AI output reviewable.
Adverse event reports and patient support programs carry personal health information. We run a privacy impact assessment, de-identify where possible and keep data in Canadian regions.
Quality, regulatory and safety data usually live in validated platforms that cannot be modified casually. We integrate through their supported APIs and exports, so your existing validation is preserved.
In a free 30-minute call we’ll look at one process, from deviations to case intake, and tell you what AI could take on, what your quality unit will need to approve it, and how long it would take.
30 minutes with a senior engineer. No sales pitch, no obligation.
