Business Solutions

Enterprise Programmes

Portfolio-scale regulatory compliance for established brands and groups: a named assessor, framework engagement, multi-market coordination, regulatory-change monitoring and agreed service levels across dozens or hundreds of products.

An established brand or group has a different problem from a startup. The question is not how to complete one safety assessment but how to keep dozens or hundreds of products compliant across many markets while the regulations underneath them keep changing. Enterprise Programmes are built for that scale.

Portfolio-scale safety assessment

We run portfolio work as a framework engagement with a named safety assessor who knows the range, rather than as a series of unrelated jobs. Cosmetic Product Safety Reports are prepared and then kept current as the annexes change, house formulation data is reused across related products, and recurring and bulk work is handled to an agreed rhythm. Many of our clients keep their entire portfolio with us, which is why the average client has around a dozen products under our care.

Multi-market coordination

A large range is rarely sold in one market, so we hold a master evidence base for each product and adapt it across markets rather than rebuilding it. We act as both UK and EU Responsible Person under one quality management system, coordinate notifications, and keep claims consistent across a range so the same product is not described one way in one market and differently in another.

Account management and service levels

An enterprise client has a dedicated point of contact, agreed turnaround and service levels, and active monitoring of regulatory change, so when an EU Omnibus act or a UK statutory instrument affects a product in the portfolio, the brand is told which products are affected and what has to change, rather than finding out at an audit. Portfolio status is reported so compliance can be managed as a programme.

A long-term partnership

The value of an enterprise relationship compounds. A named assessor who already holds the portfolio’s data assesses a new variant faster, spots a divergence between markets sooner, and can model the effect of a forthcoming annex change across the whole range. Our three on-site laboratories support the analytical and compliance testing the portfolio needs without sending work out to third parties.

How we help

We take on a portfolio as a managed programme: the safety assessments, the Responsible Person roles across markets, the claims work, regulatory-change monitoring and reporting, all under one assessor and one agreement, so a group’s compliance is held coherently rather than scattered across products and providers.

Relevant services

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CPSR

From £70 · 2 to 3 days

The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.

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Responsible Person

From £149 · per product, per year

Oxford Biosciences acts as your Responsible Person in the UK and the EU under a single quality management system, holding the regulatory obligation: PIF maintenance, SCPN and CPNP notification, labelling oversight, and cosmetovigilance.

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Global Markets

From £149

Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.

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Claims Testing

From £5,000 · 3 to 5 months

Clinical efficacy studies that generate the measured evidence a cosmetic claim needs, to a standard a regulator or a broadcaster will accept. For anti-ageing, brightening and other performance claims.

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Frequently asked questions

How do you manage compliance for a large product portfolio?

Through a framework engagement with a named assessor who holds the portfolio's data, keeps the safety reports current as the annexes change, coordinates Responsible Person roles and notifications across markets, and monitors regulatory change so affected products are flagged before an audit.

What is a CPSR?

A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.

How much do Responsible Person services cost?

Dual UK and EU Responsible Person designation is £299 per product in Year 1, reducing to £149 net of the £150 Regulatory Due Diligence credit applied to every new engagement, and £169 per product per year thereafter. A single jurisdiction, GB or EU only, is £199 in Year 1, £49 net of the credit, and £119 per year thereafter. Every new engagement is preceded by a Regulatory Due Diligence Review. All fees are exclusive of VAT.

Can one safety assessment be used to sell a cosmetic in several countries?

The underlying safety science can be reused, but the filing cannot. A single master evidence base supports many markets, yet each needs its own assessment format, registration or notification, and usually its own local representative, with the formulation re-checked against that market's ingredient lists.

Which international markets does Oxford Biosciences cover?

Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.

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