Qualis Regulatory Services helps pharmaceutical, biotech and medtech organizations turn Argentine and regional regulatory requirements into dependable processes, audit‑ready systems, and operations built to scale.
Rather than sixteen disconnected service lines, Qualis organizes its work into six practice areas that mirror how regulatory, quality, and operational problems actually show up inside a life sciences organization. Each area opens into the specific services behind it.
Strategy, classification, and submissions to get and keep products authorized in Argentina and across Latin America.
Quality management systems built to withstand inspection — and rapid remediation when they don't.
Vigilance systems that detect, evaluate and report risk across the clinical and post‑market lifecycle.
Computerized systems and ERP processes that produce evidence regulators — and your own teams — can trust.
Operational, project and diligence support for organizations changing how they work — or what they own.
Sector‑specific regulatory and quality practices for categories with their own rules and risk profiles.
Not every need calls for the same delivery model. Qualis is explicit about what it delivers directly, what it delivers with specialized partners, and where it acts purely as regional execution capacity for an international partner.
Delivered directly by Qualis, end to end.
Qualis directs the engagement; specialized partners execute defined technical workstreams.
Qualis acts as the Latin American execution and business‑development arm of an international consulting partner.
For companies who want a known starting point rather than an open‑ended engagement, these nine programs package the practice areas above into a fixed scope, timeline and deliverable set.
Executive diagnostic of regulatory status, quality system, processes, systems and top risks.
→ Diagnostic, risk map, roadmapIntensive preparation ahead of a regulatory audit or inspection.
→ Assessment, mock inspection, CAPA, trainingFull design or remediation of the quality management system.
→ Target model, documentation, governance, KPIsImplementation or strengthening of pharmacovigilance / technovigilance.
→ Operating model, SOPs, agreements, KPIsAssessment of computerized systems, data integrity and Part 11 / Annex 11 / GAMP 5 alignment.
→ Inventory, gap assessment, validation planAlignment review between GxP processes, procedures and actual SAP usage.
→ AS‑IS–TO‑BE map, gap matrix, roadmapEnd‑to‑end support for international companies entering Argentina and Latin America.
→ Regulatory map, entry strategy, budget, planSenior, part‑time direction of Quality & Regulatory Affairs.
→ Governance, prioritization, KPIs, team developmentSpecialized program for producers, fillers, importers and distributors of medical gases.
→ Strategy, QMS, validation, inspection prepFrom regulatory requirement to effective execution — that's the line Qualis is built to hold.
Diagnostics, audits, registrations, procedures, validations and specific deliverables.
Ongoing senior counsel for organizations that need expertise without adding permanent headcount.
Temporary or part‑time direction of Quality, Regulatory Affairs, Pharmacovigilance or transformation projects.
Dedicated teams and governance to restore compliance and prepare for (re)inspection.
Continuous management of regulatory processes, vigilance, documentation, KPIs or regional coordination.
Technical and commercial interface in Argentina / Latin America for international firms.
Tell us about the product, the market, and the timeline — Qualis will tell you what it actually takes to get there, and what it would take to work together.
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