Initial regulatory audit

(The first step before building a PIF)

Before preparing a PIF or investing more time and money, it's worth being clear on one thing: is your product regulatorily viable, or are there hidden risks? This audit offers a quick, practical review of your product so you know exactly where you stand and what needs to happen next.

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What we review:

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• Formula (ingredients and obvious restrictions)

• Claims and marketing messages

• Basic labelling

• Viability for the European market

What you get:

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• A clear report (no legal jargon)

• What's compliant

• What needs correcting

• What documentation is missing

• Whether your product is viable as it stands

Creation and maintenance of PIF

The PIF done right from the start — and properly maintained thereafter.

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The Product Information File (PIF) is mandatory for selling cosmetics in the European Union under Regulation (EC) No 1223/2009. But it's not just a document you need to have — it's the technical backbone of your product. At Cláritas Regulatory, we don't just prepare the PIF: we build a solid regulatory foundation so your brand can grow without unwanted surprises.

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PIF preparation includes:

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• CPSR (Parts A + B) prepared and signed by a qualified safety assessor

• Regulatory review of the formula and INCI list

• Ingredient compliance and restrictions check

• Mandatory labelling review

• Regulatory assessment of claims

• Complete technical dossier ready for future updates

PIF maintenance includes:

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• Monitoring of relevant regulatory changes

• Updates for labelling or technical documentation adjustments

• Annual preventive review

• Basic support for queries or inspections