LIFF RegTrack

LIFF RegTrack is the regulatory operations platform for companies that answer to health, agricultural and environmental authorities, spanning human pharma, animal health and agro. It structures, automates and makes traceable the operational work of regulatory affairs, while the technical and strategic regulatory decision remains with the customer and its qualified professionals. A change in formula, supplier, label or manufacturing site sets off a chain of obligations: regulatory event, classification of the obligation, risk assessment, collection of documents and evidence, dossier drafting, human validation, filing and post-filing tracking. The same chain repeats across human pharma, animal health and agro; what changes is the competent authority, not the operational problem.

RegTrack covers three regulatory fronts on one platform. RegTrack Farma addresses the human pharma life cycle under ANVISA, including CMED economic regulation. RegTrack Animal addresses the veterinary cycle under MAPA with a One Health lens. RegTrack Agro addresses the coordination of MAPA, IBAMA and ANVISA, from registration to re-evaluation. Each front has its own flows, document sets and risk matrix, and customers can adopt one front at a time or an integrated model across multiple regulated markets.

Implementation starts by mapping the customer's regulatory activities. Each routine is classified by AI readiness, regulatory complexity, automation potential, required human supervision and regulatory or sanitary risk, and that diagnosis drives a wave-based rollout: repetitive, low-impact routines first, moderate-risk activities with preliminary analysis and human validation next, and critical or strategic matters last, where the platform organizes information and alternatives and the customer decides. High complexity, high risk or low readiness stays with the human, by design.

RegTrack identifies and classifies regulatory events, determines the applicable obligation and authority, scores it against the risk matrix, organizes documents and evidence, structures dossiers and drafts communications, routes technical approval by risk level, prepares the assisted filing and tracks deadlines, requirements and status in a single auditable trail. Final regulatory framing, submission strategy, technical and scientific sufficiency, approval of labeling and promotional material, batch release, pharmacovigilance decisions and the signature of official acts remain human decisions; RegTrack prepares, organizes and recommends, and the responsible professional decides and signs. Analyses are anchored to official sources and current rules, every relevant step records documents, versions, reviewers and approvals, and when there is an inconsistency, a missing document or a normative divergence, the flow stops and an incident is opened, so failures stay visible and treatable rather than silent.

The service is delivered as a managed service. Depending on the customer's specific requirements, the solution may run on AWS or involve AWS infrastructure spanning functional categories such as hosting and compute, data processing, AI-assisted analysis, security and identity management, and document and data storage, with data residency, encryption and audit logging handled according to the agreed scope. Information security practices include logical segregation by tenant, no use of customer data for model training, vaulted credential storage and complete usage and audit logs.