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PRJ—03 / 2024PharmaceuticalPharmaceutical regulatory labeling

Proclin Pharmapharmaceutical regulatory labeling

Redesign of the pharmaceutical labeling system under INVIMA requirements — from the editorial template to the approval flow, focused on traceability, clinical legibility, and response times for industrial batches.

Proclin Pharma
ClientProclin Pharma
IndustryPharmaceutical regulatory labeling
Year2021 — 2024
RoleDirection + design
ScopeFull system
Context001
Challenge

Compliance without sacrificing speed.

The previous system accumulated observations at every batch review: typographic inconsistencies, confusing warning hierarchy, long internal approval times.

The brief: a redesign that would pass INVIMA audits without observations and that the team could sustain at industrial pace, batch after batch, without reopening every artwork.

Approach

Editorial templates, not loose artworks.

We built a master template with the regulatory hierarchy embedded — mandatory fields, safety margins, typographic zones, and coded warnings.

We defined a step-by-step documented approval flow with archivable evidence for each batch. Design went from deliverable to auditable process.

Gallery002
Image · Master label
Image · Master label
Image · Primary packaging
Image · Primary packaging
Image · Industrial batch
Image · Industrial batch
Image · Auditable flow
Image · Auditable flow
Image · Typographic detail
Image · Typographic detail
Result · Monthly batch
+100K /mes

Labels produced per month, zero observations.

Monthly batches sustained with INVIMA approval and no rework. Auditable, documented, scalable to real production volume.

Credits003
DirectionÓscar · Grafismo Comunicaciones
Regulatory designEditorial team · Grafismo
Technical validationProclin Pharma technical direction
ProductionCertified vendors · CO
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