Cosmetovigilance

Market entry requires a vigilance system most cosmetics manufacturers have never had to build

About

Selling cosmetics in the EU, the UK, or almost any regulated market requires a functioning vigilance system before the first unit reaches a shelf: a named Responsible Person, a Cosmetic Product Safety Report, a process for Serious Undesirable Effect reporting. For a small manufacturer or trader, none of this exists on day one, and there is rarely anyone in-house who has done it before. The gap usually stays invisible until a regulator asks a specific question, or a customer complaint turns into a legal claim, and the answer needs to already exist on paper. We build the vigilance system before that day arrives: Responsible Person governance, safety documentation, and a reporting process ready to withstand scrutiny from the start.

From the Trenches

Common Challenges we Solve

The Challenge

Responsible Person Governance

01

Every cosmetic product on the EU market needs a named Responsible Person who carries personal liability for its safety. Many small manufacturers fill the role on paper, without the authority, file, or process behind it to hold up if it is ever tested.

The Solution

A Responsible Person structure with the substance behind the title: documented decision authority, defined escalation lines, and a file built to survive scrutiny from a regulator or a claimant.

The Challenge

CPSR & Product Information File

02

The Cosmetic Product Safety Report and Product Information File are the first documents a market surveillance authority asks for, and the first thing an opposing lawyer requests in a liability claim. Many manufacturers only discover gaps in the toxicological assessment once one of the two comes asking.

The Solution

A CPSR and PIF built before either request arrives, with the safety assessment and ingredient data structured to answer the questions regulators and courts actually ask.

The Challenge

SUE Reporting & Complaint Handling

03

Serious Undesirable Effect reporting runs on its own thresholds, timelines, and portals, separate from any general consumer complaint process. Without a defined process, a single bad reaction report can turn into regulatory attention with no paper trail to show it was handled correctly.

The Solution

A complaint intake and SUE reporting process that captures every report correctly the first time, with documentation that shows a regulator or claimant it was handled the way the Regulation requires.

The Challenge

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The Solution

The Challenge

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The Solution

The Challenge

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The Solution

See our Other Areas of Expertise

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Cosmetovigilance

Building Your Commercial-Ready PV System:

The Founders

Independent pharmacovigilance leadership for small and mid-size pharma and biotech.

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Building PV systems for whatever situation put them under strain.

Stefan Brüning
Co-Founder and Consulting Practice Lead
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Responsible for leading human health and veterinary PV audits to help organisations build robust, inspection-ready PV systems.

Janine Gavin
Co-Founder and Audit Practice Lead
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“Pharmacovigilance is a fundamental responsibility to patients, not just a regulatory checkbox. We make sure your systems reflect that.”

“Solid compliance is built before the auditor knocks. We help you get there — and stay there.”