Launching a product?

Don't forget to budget for compliance!

Regulatory compliance can sometimes feel like an unexpectedly large line in a product development budget.

This is particularly true for companies launching into a new market for the first time. At Bloom, we often speak to businesses once the product has already been developed, the packaging designed and manufacturing is underway. At that stage, compliance can feel like an additional cost that has appeared just before launch.

It is also easy to underestimate what sits behind that cost.

Regulatory compliance is rarely one quick check. Done properly, it can involve detailed formula assessment, several rounds of artwork review, specialist safety expertise, gathering and checking technical evidence, reviewing claims and completing the steps needed to place the product legally on the market.

Much of that work also involves experienced professional judgement rather than simply following a checklist.

Understanding what is actually involved makes it easier to budget realistically for compliance and to see why planning for it early can ultimately save both time and money.

A label review is rarely just one review

Checking a product label involves much more than confirming that the mandatory information is present.

The wording, ingredients, warnings, claims, responsible business details and other information may all need to be considered against the requirements of the market where the product will be sold.

And it is very common for the first review to identify changes.

Artwork is then amended and checked again. Sometimes the changes create further questions, or other parts of the artwork are changed at the same time and also need to be reviewed.

So what may initially sound like “a label check” can in practice involve several stages before the final artwork is ready to approve.

This is why regulatory quotations often need to allow for a reasonable amount of review and follow-up rather than assuming that the first version will already be compliant.

It is also why involving regulatory teams before artwork is finalised can save both time and money.

One formula may need several different checks

A formulation that can legally be sold in one country will not necessarily meet the requirements of another.

If a product is being launched across several markets, the ingredients may therefore need to be checked against several different regulatory sources.

Restrictions can differ. Permitted concentrations can differ. Required warnings can differ. And regulations continue to change.

The work is not simply identifying whether an ingredient appears on a list. It is understanding which requirements apply to that ingredient in that particular product and whether there are conditions, concentration limits or other requirements that affect how the finished product can be sold.

For a multi-market launch, that work may need to be repeated across a number of regulatory systems.

That can be time-consuming, but identifying an issue while a formulation is still being developed gives businesses far more options than discovering it once thousands of units have been manufactured.

Safety assessments are specialist professional work

For cosmetics, one of the most important parts of compliance is the safety assessment.

The Cosmetic Product Safety Report is not simply another document needed to complete the Product Information File. It is the professional assessment that brings together information about the formulation, ingredients, exposure, product use and supporting safety data to determine whether the finished cosmetic is safe.

That assessment must be undertaken by someone with the appropriate qualifications and expertise.

There is therefore a significant amount of scientific knowledge behind the final report, even when the document itself may look relatively straightforward.

This is an important distinction when considering cost. Businesses are not simply paying for a document to be produced. They are paying for the specialist assessment behind it and the professional judgement involved in reaching a safety conclusion.

Ultimately, this is one of the most important safeguards protecting the person who will actually use the product.

Good compliance depends on good evidence

Another part of the work that is easy to underestimate is gathering and reviewing the supporting documentation behind a product.

For cosmetics, for example, the Product Information File and Cosmetic Product Safety Report rely on information supplied by manufacturers, ingredient suppliers, laboratories and other parties.

Simply having a document is not always enough.

The information needs to be relevant, complete, current and of sufficient quality to support the regulatory assessment.

Sometimes everything required is readily available. In other cases, documents need to be reviewed, gaps identified, suppliers contacted and replacement or additional information requested.

That work takes time, but it is an essential part of due diligence. A regulatory file filled with documents is not necessarily a good regulatory file if those documents do not provide the evidence needed.

The better the information available at the beginning of a project, the smoother, and often more cost-effective, this process is likely to be.

Claims require judgement, not just a yes or no

Claims can be another significant area of regulatory work.

Businesses quite rightly want to explain what makes a product effective or different. But claims need to be truthful, honest and supported by appropriate evidence.

There can also be a wider question: what does the claim make the product appear to be?

A cosmetic claim, for example, can potentially stray into medicinal territory.  Evidence supporting a claim does not automatically mean that the claim is appropriate under the regulatory framework being used to place the product on the market.

This is where regulatory expertise becomes particularly important.

There is not always a simple list that says exactly which wording is acceptable. The reviewer may need to consider the wording, the evidence, the product itself, the way the claim is presented and what consumers are likely to understand from it.

That professional judgement is part of the regulatory work too.

Reviewing claims while marketing copy and artwork are still being developed gives teams more room to find wording that is both compliant and commercially useful.

Even administrative steps need to be accurate

In many markets, products also need to be notified or registered with the relevant authorities before they are placed on the market.

The process may look administrative, but the information submitted needs to be accurate and consistent with the product that will actually be sold.

Those submissions can involve detailed product, ingredient, packaging and responsible business information, and mistakes can cause problems later.

Getting this right helps products move into the market smoothly and ensures authorities have the information they need once the product is available.

Compliance also needs realistic time

Budget is only part of the planning. Businesses also need to allow enough time for the regulatory work to be completed properly.

Some activities can be completed relatively quickly when good information is already available. Others depend on supplier documents, specialist safety assessment, clarification of technical information or changes to formulas, claims and artwork.

A review may also identify issues that need to be resolved before another stage can begin.

This means the timetable is not always determined simply by how long it takes someone to perform the initial review.

A consultant may be able to review an artwork quickly, for example, but if ten changes are identified, the business still needs time to amend it and the revised version needs to be checked. A safety assessor may identify missing supplier information that has to be obtained before the assessment can be completed.

That is why a full compliance project cannot always be compressed into a few days or weeks simply because the planned launch date is approaching.

Setting a launch date before understanding the regulatory work required can create unnecessary pressure and, in some cases, leave the business with very few practical options.

Leaving compliance until the end can cost more

Perhaps the most important point is that the cost of regulatory work is only one part of the commercial picture.

If a formula needs changing after manufacture has been planned, the cost can be significant. If claims need rewriting after packaging has been printed, artwork may need to be replaced. Missing supplier information can delay a safety assessment. A problem identified shortly before launch can put retailer or distributor commitments at risk.

The earlier an issue is identified, the more options a business usually has for resolving it.

Once stock has been manufactured, packaging printed and launch commitments made, those options can become much narrower and much more expensive.

This does not mean completing every regulatory activity at the beginning of development. It means understanding the regulatory pathway early enough to know what work will be required, how much budget to allow and when regulatory decisions need to be made.

Budget for compliance as part of the product

When planning a launch, regulatory compliance should sit alongside formulation, manufacturing, packaging, design and marketing in the project budget.

If a product is going to be placed on a regulated market, establishing that it is safe, compliant, appropriately supported and correctly placed on that market is part of the cost of developing and launching it.

The exact cost may vary as it reflects the work involved: the time spent reviewing and re-reviewing information, the specialist expertise required, the number of markets being assessed, the quality of the evidence available and the professional judgement needed to reach sound regulatory decisions.

That work ultimately protects both the consumer using the product and the business whose name is on it.

At Bloom Regulatory, we try to help businesses understand that work before they are committed to a launch date or have spent the rest of their development budget. From an individual formula or label review to a full multi-market launch, early discussion allows us to identify what will be needed, where specialist input may be required and what a realistic budget and timetable should look like.

Compliance will always require investment. Planning for that investment early is usually far easier than dealing with the cost of getting it wrong later.

Amanda Isom