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Cosmetic Product Information File (PIF) Services for Cosmetic Products

Ensure full compliance with EU and UK cosmetic regulations with a professionally compiled Product Information File (PIF). Patient Guard supports manufacturers, brand owners, and importers by preparing, reviewing, and maintaining PIFs to meet regulatory requirements and facilitate smooth market access.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

Product Information File (PIF) Services for Cosmetic Products

Cosmetic manufacturers must prepare and maintain a Product Information File (PIF) to demonstrate compliance with EU Cosmetic Regulation (EC) No 1223/2009 and UK cosmetic regulations.

A Product Information File is a mandatory requirement for placing cosmetic products on the market in the European Union and the United Kingdom. It must contain detailed information about the product, including safety data, formulation, manufacturing processes, and supporting documentation.

Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with PIF preparation, documentation review, and regulatory compliance.

Without a compliant PIF, cosmetic products cannot be legally placed on the market or registered on the Cosmetic Product Notification Portal (CPNP) or the Submit Cosmetic Product Notifications (SCPN) system.

We provide expert PIF services for cosmetic manufacturers worldwide, ensuring your documentation is complete, compliant, and audit-ready.

Speak to our regulatory experts today to ensure your cosmetic products meet EU and UK regulatory requirements.

David Small - Patient Guard - CEO and Founder

"In the cosmetics industry, trust is built on transparency. We treat every PIF with the same level of scientific rigor we apply to medical device technical files, ensuring that your ingredient data, manufacturing standards, and safety assessments are perfectly aligned for market success."

David Small BSc (Hons), MSc, MTOPRA

Founder and CEO

Why Choose Patient Guard for PIF Services?

Dual Market Alignment

Our regulatory specialists ensure your Product Information Files are flawlessly optimized for both UK and EU cosmetic regulations seamlessly.

End-to-End Compliance

We handle everything from initial formula screening and documentation collection to compiling and updating the final structural file framework.

CPSR Integration Ready

We smoothly weave your mandatory Cosmetic Product Safety Report data directly into the PIF, ensuring a perfectly audit-ready setup.

Lifecycle Document Support

We support your brand through future formulations, manufacturing variations, and ongoing regulatory changes over the device's market span.

Trusted Professional Team

Since 2017, hundreds of global brands have trusted our professional services firm to navigate complex product safety frameworks safely.

Pragmatic Data Management

We avoid over-complicated administration, organizing your technical compliance dossiers into clean, accessible formats for authorities.

What Our PIF Service Includes

Product Safety Report (CPSR)

Verifying the inclusion of a rigorous, fully signed Cosmetic Product Safety Report to establish product composition safety.

Device & Formula Specification

Compiling clear product descriptions, identification metrics, exact structural formulas, and physical/chemical raw material profiles.

GMP Method Verification

Documenting your manufacturing methods to demonstrate complete compliance with Good Manufacturing Practices (ISO 22716 standards).

Labelling & Claims Review

Reviewing product text labels, packaging compliance, warning symbols, and structuring supporting data for all cosmetic claims.

Animal Testing Exemptions

Reviewing development trails to compile precise documentation confirming complete compliance with strict animal testing prohibitions.

Authority Readiness & Updates

Structuring the file framework to ensure it is readily accessible to UK and EU competent authorities while managing lifecycle updates.

Who Requires a Product Information File?

PIF Regulatory Requirements

Under EU and UK cosmetic regulations:

A PIF must be maintained for each cosmetic product
The PIF must be readily accessible to authorities
A CPSR must be included within the PIF
Manufacturing must comply with GMP (ISO 22716)
Labelling and claims must meet regulatory requirements
The PIF must be kept up to date throughout the product lifecycle

Our Process

Product Information

We assess your product formulation, ingredients, and documentation

Data Collection

We gather all required safety, manufacturing, and supporting data

PIF compilation

We compile your Product Information File in line with regulatory requirements

Compliance Review

We verify that your documentation meets EU and UK regulations

PIF Delivery

We deliver your PIF and provide ongoing support for updates and compliance

Cosmetic types we support

We support a wide range of cosmetic products, including:

Cost of Service

Premium

Product Information Files

£ 500

from

Support your market access with expertly prepared, fully compliant Cosmetic Product Information Files (PIFs). Pricing starts at £500 per PIF, with preferential rates for multiple products.

Features

Fully compliant with EU and UK cosmetic regulations
Expert review by regulatory specialists
Fast turnaround to support market entry
Scalable pricing for product ranges

Get Started

Time Lines

Submit your product details

Provide formulation, ingredient data, packaging, and supporting documentation

PIF preparation and review

Our experts compile and verify your Product Information File to ensure full compliance

Delivery and ongoing support

Receive your completed PIF, with optional updates and support for future regulatory needs.

Efficient delivery: PIFs are typically completed within 5–10 working days, with timelines tailored to product complexity and data readiness.

Frequently Asked Questions (FAQs)

What is a Product Information File (PIF)?

A PIF is a regulatory document that contains all the information required to demonstrate that a cosmetic product is safe and compliant with EU and UK cosmetic regulations.

Is a PIF mandatory?

Yes, a PIF is a legal requirement for all cosmetic products placed on the EU or UK market.

What does a PIF include?

A PIF includes the Cosmetic Product Safety Report (CPSR), product description, manufacturing information, labelling details, and supporting data.

How long must a PIF be kept?

A PIF must be retained for at least 10 years after the last batch of the product has been placed on the market.

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   Jay Verma 
 15 days ago
 
 
 Trustindex verifies that the original source of the review is Google. I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
  
 
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   Munna P 
 68 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
  
 
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   Peter Reeve 
 94 days ago
 
 
 Trustindex verifies that the original source of the review is Google. STEPPER design, manufacture & distribute eyewear across the globe.  With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
  
 
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   Derek Timm 
 95 days ago
 
 
 Trustindex verifies that the original source of the review is Google. For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd   The staff are fantastıc  nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them  Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
  
 
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   BMSCriticalCare 
 132 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Great service, very helpful and always willing to answer any questions we have,
  
 
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   Thomson Software 
 803 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner.  He was friendly, patient and willing to go the extra mile.  Excellent service.
  
 
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   Hannah Maddison 
 906 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Fantastic, knowledgeable team that are always there to help.  My appointments have always been booked in very promptly and have always ended with all my queries resolved.  I have found the team very flexible and their breadth of knowledge is second to none.  Patient Guard are without doubt my go-to for all the regulatory aspects of my medical device role.
  
 
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   Richard Crow 
 941 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Patientguard are an excellent source of Medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with Technical Files all the way through to using their ISO Templates to implement our ISO 13485 system.
  
 
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   George Kitching 
 944 days ago
 
 
 Trustindex verifies that the original source of the review is Google. David Small and PatientGuard have been extremely helpful and supportive in assisting us with producing and updating our Technical File and Appendices for MDR certification.
  
 
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   Tracey Slater 
 944 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Patient Guard have been a great support service to Cormed, providing help and advice promptly when ever requested.  They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.
  
 
 
  
 
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