
Medical Device Regulatory Consulting Services Explained
Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.
Patient Guard provides Cosmetic Product Safety Report (CPSR) services for cosmetic products, supporting compliance with UK cosmetic regulations. We ensure your CPSR is scientifically robust, compliant, and ready for market access.
Cosmetic manufacturers must prepare a Cosmetic Product Safety Report (CPSR) to demonstrate that their products are safe for human use in accordance with EU Cosmetic Regulation (EC) No 1223/2009 and UK cosmetic regulations.
A CPSR is a mandatory requirement for placing cosmetic products on the market in both the European Union and the United Kingdom. It forms a key part of the Product Information File (PIF) and must be completed by a qualified safety assessor.
Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with CPSR preparation, safety assessments, and regulatory compliance.
Without a compliant CPSR, cosmetic products cannot be legally registered on the Cosmetic Product Notification Portal (CPNP) or the Submit Cosmetic Product Notifications (SCPN) system in the UK.
We provide expert CPSR services for cosmetic manufacturers worldwide, ensuring your products meet safety requirements and are ready for market access.
Speak to our regulatory experts today to ensure your cosmetic products are fully compliant and safe for consumers.
We have supported cosmetic manufacturers with UK regulatory compliance for over 9 years.
We support start-ups, SMEs and global brands with cosmetic compliance and UK market access.
We deliver CPSRs quickly while ensuring full compliance with EU and UK cosmetic regulations.
We provide clear annual or project pricing with no hidden fees, helping you budget with confidence.
We compile and assess all relevant data, including formulation details, toxicological profiles, exposure assessment, and stability data.
We prepare the formal safety assessment, including conclusions on product safety, labelling requirements, and conditions of use.
We assess all ingredients against regulatory restrictions and toxicological data to ensure compliance.
We verify that your cosmetic product complies with EU and UK cosmetic regulations.
We ensure your CPSR aligns with requirements for product notification in both the EU and UK.
Under EU and UK cosmetic regulations:
We assess your formulation, ingredients, and product details
We gather toxicological, stability, and safety data
We perform a full CPSR safety assessment
We prepare your CPSR (Part A and Part B)
We ensure your CPSR is compliant and ready for regulatory submission
We support a wide range of cosmetic products, including:
From
Ensure regulatory compliance and market readiness with expertly prepared Cosmetic Product Safety Reports (CPSRs). Pricing starts from £1,000, with preferential rates for multiple products.
Provide full ingredient composition, specifications, and supporting documentation
Our qualified safety assessors perform a full toxicological review and compile the CPSR
Receive your completed CPSR, ready for notification, with ongoing regulatory support if needed
Fast turnaround: most CPSRs are delivered within 7–15 working days, subject to completeness of product information.
As we move further into 2026, the regulatory requirements for the UK and EU markets are no longer identical. For brands selling in both regions, understanding the differing enforcement timelines is critical to avoiding wasted stock or legal non-compliance.
Key Divergence Alerts:
EU Market (Omnibus VIII): Under Regulation (EU) 2026/78, bans on specific CMR substances (including various nano-materials and Silver Powder) come into full force on May 1, 2026.
UK Market (Great Britain): The UK follows its own timeline via the UK Amending Instrument (SI 2026/109). While many restrictions align, certain ingredients—most notably Hexyl Salicylate—have a later enforcement date in the UK, applying from August 2026.
A “one-size-fits-all” safety assessment may no longer be sufficient. Our assessors ensure that your CPSR Part B explicitly addresses these diverging grace periods. We provide clear guidance on:
Transition Timelines: When exactly you must stop placing non-compliant products on the market in each region.
Sell-Through Periods: How long existing stock can remain on shelves in the UK vs. the EU.
Reformulation Strategy: Prioritizing ingredient changes to meet the earliest deadline (May 1st) to maintain uninterrupted access to the European Single Market.
Expert Tip: Don’t get caught out by “shadow bans.” Even if a substance is legal in the UK until August, your EU Responsible Person cannot represent that product after May 1st. We help you synchronize your compliance strategy to save costs.
A CPSR is a safety assessment document that demonstrates a cosmetic product is safe for human use in accordance with EU and UK cosmetic regulations.
Yes, a CPSR is a legal requirement before placing a cosmetic product on the market in the EU or UK.
A CPSR must be prepared by a qualified safety assessor with appropriate expertise in toxicology and cosmetic safety.
The timeline depends on product complexity and availability of data, but typically ranges from a few days to a few weeks.
Starting May 1, 2026, several CMR substances (including nano and non-micronised silver) are prohibited, and new restrictions apply to Hexyl Salicylate. We are currently performing emergency formula reviews to ensure your safety assessments remain valid
Generally, products placed on the market before May 1st can be sold until stock is exhausted, but no new batches can be released
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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