Defined dossier work
One or a few products, with bounded deliverables, review cycles and milestones.
- Best fit
- Clearly identified products and dossier work.
Pharmaceutical Regulatory Affairs in ChileYour portfolio.
Your portfolio.
Structured
for Chile.
From pharmaceutical dossiers to a local operating structure. Senior regulatory direction, built around what your company needs next.
Based in Chile. Working with international teams.
ISP pharmaceutical submission supportCTD dossier reviewChile Ministry of Health pathway mapping
What we doRegulatory expertise.
Regulatory expertise.
Connected to your operation.
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 deliverFrom one dossier
From one dossier
to ongoing operations.
Your regulatory need defines the work. DBD, ENTRY Chile and OPERATE adapt its delivery to your products, portfolio and ongoing responsibilities.
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.
Your starting pointWhat do you need
What do you need
to put in place in Chile?
Choose an objective to see the relevant service and what to prepare.
A useful starting pointDose Dumping / ENGuide to pharmaceutical registration ↗
Start with the products and their dossiers.
A product-specific registration scope can cover dossier review, document coordination, submission and agreed follow-up.
For an initial conversation
- Products and dosage forms
- Manufacturers and manufacturing sites
- Current dossier status and intended portfolio
Share a non-confidential overview. This guide helps you navigate our services; product eligibility and the scope of work require individual review.
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
Monthly pharmaceutical industry intelligenceFor 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.
Start a conversation