Defined dossier work
One or a few products, with bounded deliverables, review cycles and milestones.
- Best fit
- Clearly identified products and dossier work.
The regulatory structure your pharmaceutical portfolio needs in Chile.
SERTURNER helps international pharmaceutical companies assess dossiers, organize portfolios and build a fit-for-purpose local regulatory structure—with senior direction, clear responsibilities and continuity beyond submission.
ISP pharmaceutical submission supportCTD dossier reviewChile Ministry of Health pathway mapping
What we doThree regulatory pillars.
Three regulatory pillars.
One coherent Chile structure.
Each engagement starts from the regulatory need. The delivery model then adapts to one dossier, a portfolio or an ongoing operating requirement.
Pharmaceutical product registrations
Product-specific dossier review and registration work, delivered through a defined scope and controlled milestone.
Explore registrations →Local holder & regulatory lifecycle
Selected local-holder structures and ongoing lifecycle work with explicit governance, risk and responsibility boundaries.
Review the holder model →Pharmaceutical company setup
A fit-for-purpose Chilean regulatory structure coordinated across legal, tax, operational and sanitary layers.
Map the four layers →How we deliver
A structure designed around the decision.
DBD, ENTRY Chile and OPERATE are delivery modes—not separate promises. The regulatory pillar defines what must be solved.
Portfolio execution
A prioritized portfolio advanced in agreed waves from a common baseline.
- Best fit
- Several products requiring sequencing and shared governance.
Regulatory continuity
A configurable service catalogue for a defined inventory, period and capacity.
- Best fit
- Ongoing lifecycle responsibilities after the initial scope.
Founder-led
Senior regulatory direction stays close to the work.
Boris Araya Ibarra leads critical regulatory decisions, the primary client relationship and final review of work delivered under SERTURNER's responsibility.
About SERTURNER →Connect with Boris on LinkedIn ↗Published by SERTURNER
Dose Dumping
Pharmaceutical industry intelligence for decision-makers: Chilean market developments in Spanish and regulatory guidance for international teams in English.
Chile, made workable
Define the next controlled step.
Share a non-confidential overview of your products, dossier baseline and intended local structure.
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