Why buying toxicology on price alone may cost more later
Reliable toxicology support is one of the more expensive items in a product development budget, and the temptation to chase the lowest quote is understandable. But is the cheapest price always the best value? Here we examine why the right scope, rather than the lowest cost, is what protects your submission, your route to market and your budget.
Most toxicology support is bought like a commodity. Three quotes, the lowest number wins, and the file moves to the next line item. It is a natural way to control a budget. Toxicology is also one of the more expensive parts of a product's development.
The reason is straightforward. You are not buying a report, you are buying the expertise, experience and judgement that collectively creates a report that holds up against regulatory scrutiny. That expertise, experience and judgement, is usually invisible at the point of purchase. Think about a structural weld. It can look flawless, pass inspection, and carry everyday load for years. Its real quality only shows under pressure. A regulatory submission is no different. It can read well, clear internal review, and sit quietly in a dossier while its weak points stay hidden, until a reviewer leans on them. In toxicology, the regulator is the pressure, and that will exert itself against the judgement of the toxicologist.
What are you actually buying?
A lot of toxicology looks, from the outside, like document production. A company needs a justification, a response to a query, or a full submission package, so it hires someone to produce one. That work is real. It is also the smallest part of the value. You could probably get AI to create a report or opinion, and it might look like the real deal.
The value sits in the decisions behind the document.
• What evidence is needed?
• What are the appropriate and trusted sources of information?
• How do those sources weigh up when they contrast?
• How to read a borderline or conflicting result?
Take a simple case. An in silico (Q)SAR screen returns a flavour ingredient as negative or equivocal for a genotoxic alert. To the untrained eye (the cheap option), that result is logged and the file moves on. A toxicologist demonstrating good judgement asks the next questions. Is the model appropriate for this structure? Is there in vitro data to confirm it? Does the conclusion hold up under a weight-of-evidence review?, and would it survive a regulator who has rejected a similar scenario before? Skip those questions and they do not disappear. They come back months later as a deficiency letter, when they are far harder to answer.
A toxicologist demonstrating good judgement also knows when to do less. A hazard that looks alarming on paper can be irrelevant at the real exposure, once dose, route and use pattern are accounted for., or the pre-clinical carcinogenicity findings have no human relevance. Spotting these quick wins can save a client an entire testing programme. The skill is not doing more or less; it is knowing what matters.
Lastly, a company should interrogate any quote. Is the cheaper option based on a low hourly rate or a lower expected number of hours they will spend. A good toxicologist does not rush nor cut corners, nor should they charge for unnecessary work.
The cheaper option looks fine until it is tested
A lean scope is attractive at the start. Narrower brief, smaller cost, easy sign-off. The problem only shows when the work does not fully answer the regulatory questions.
A position built upon a thin justification, using an unsupported read-across chemical, or a quick reading of a small selection of data rarely fails on day one. It fails later, as a deficiency question, a demand for more testing, a question on the validity of a statement, or a forced change to the strategy. And problems travel in packs. One argument that fails interrogation, will open up the remainder of the data to scrutiny. Anyone who has worked on a TPD Article 7 justification or an FDA deficiency cycle for a PMTA has seen this happen.
Most companies meet each deficiency question for the first time. An experienced toxicologist has answered the same types of question across many companies and many submissions, allowing them to avoid the issue, or failing that, know how to respond. A company who did not get it right the first time has to expedite a fix, and expediting fixes can be expensive.
Therein lies the issue, a company will mostly know what they want, but they do not understand the depth of knowledge or quantity of detail that is required. It is easy to put a package of work out for tender aiming to get a bargain deal. When the protocol is fixed and the scope requires little judgement, as long as the company delivers on time and to a high quality, cost may be the most important factor, however, with toxicology, simply put, you do not know what you are paying for.
The clock you cannot see
There is one cost that never appears on a quotation, and it is often the largest. While your submission fails review leading to deficiencies or even a denial order, or it takes longer to review as the FDA struggle to make sense of the conclusions drawn, the market does not wait. Competitors launch, iterate, and take shelf space. A window that was open when you filed can be half closed by the time you are approved. No cost you have ever saved by taking the cheaper option, will ever match the earnings you have lost by being late to the party!
What experience actually means
Experience is an overused word in this industry, so it is worth being clear about what it means. It is:
• being focused on the task in hand and the time it will
take,
• being cognisant of the guidelines and regulations, and where there is ambiguity,
• remembering each difficult issue or FDA deficiency question you have seen before and preventing it early
rather than answering it against a clock,
• spending sufficient time and using expertise to create the right read-across arguments and robust justifications,
• learning from submissions that failed, and understanding why they failed, so the same gap or error is not built into the next one,
• reading a regulatory notification the way the national competent authority intended, not the way the author interpreted.
• seeking other opinions to support your arguments.
There is a harder-won kind of experience too. Regulator expectations and guidance are not always written down; they typically exist only in the minds of the regulators. Over many submissions we have seen guidance created or revised in the direction our existing submissions had already taken. This demonstrates a good toxicologist must also listen to the industry chat, make informed choices and make sometimes hard decisions. It also comes from rapport built with regulators over time, which brings earlier clarity on approach and expectations.
This sixth sense is the difference between anticipating a challenge and being surprised by one. It matters most where the guidance is vague or not documented, or where novel product types are the norm and the rules no longer match; a great description of the nicotine, cosmetic, pharmaceutical and medical device industries in the world today.
The part that does not fit on a sales page
A good toxicologist cannot make an unsafe product safe by clever wording. No amount of careful phrasing directs a thin evidence-base into a strong one, or a poor exposure margin into a defendable one. The science is what it is, and a regulator will see it plainly. Most importantly, the customer or patient relies on safety assessment that protects them from harm.
A good toxicologist cannot make an unsafe product safe by writing about it well.
That is why independence is not optional. It is the core of the toxicology service. The job is to assess the science objectively and to say what it shows, even when that is not what the client wants to hear. Sometimes the most valuable sentence in an engagement is the difficult one. “Your formulation or product carries a risk to the customer/patient that will not survive review”. or “Your data does not support the claim your commercial team has already made”.
Delivered early, while there is still time to reformulate, generate more data, or change course, that honesty is worth more than any polished report. It protects the client long before a regulator is ever involved and will save a lot of time and money. And it is precisely the thing you cannot expect from toxicology support chosen on price alone, where the incentive is to give you what you asked for rather than what you needed.
It does not stop at submission
A product does not stop needing toxicology once it is approved. Reformulations, new variants, a shifting impurity profile, revised guidance, new exposure assumptions, a fresh question from the market or the regulator, any of these can reopen the file.
A toxicology strategy that thinks about the life cycle from the start and builds a position that bends without breaking, will help to avoid further costs later.
Right scope, fair price
None of this is an argument for paying more. The most extensive option is not the right answer any more than the cheapest one is. There are four scenarios:
• Under-scoped: the right work, but not enough of it to save cost, leaving a gap a regulator will find.
• Over-scoped: more depth than the product’s risk warrants, so you pay for testing that is not needed.
• Cheap and under-qualified: not just lean but produced without the judgement to know what it should have contained, which is dangerous, because it looks like value until it is scrutinised.
• Fair value: scope matched to the product, to the regulatory question, to your risk appetite, albeit with a toxicologist not frightened of giving bad news.
The only scenario is the last one. A lean scope can be perfect for an early GO /NO-GO decision, but it needs to be followed up with a comprehensive package.
The only choices with the fair value scenario lie with appetite for risk, and this is typically linked to budget. However, different deliverables from the toxicologist lie only with the uncertainties of an ever-changing industry, not from perspective of how deep the pockets are.
Appointing your Toxicologist?
Before you appoint a toxicologist, it is worth talking to them directly, and not the company that may outsource to an unknown associate. These are the important questions:
• Do they understand your product category and the regulatory route it has to travel?
• Can they tell you, now, where the submission is most likely to be challenged?
• Have they handled the same challenges from the same regulators before?
• How will they tell you when the science does not support the position you want?
• What additional work may need to be done throughout the process?
The answers reveal far more than the headline figure on the quote.
The bottom line
The cheapest option is not automatically wrong. It just has to be chosen with open eyes, aware of what it leaves out and the risk it leaves behind. Value in toxicology comes from setting the right strategy, reading the evidence honestly, seeing the questions before they are asked, and building a position that supports the product long after its first submission.
This is how we work at Broughton. We do not aim to be the cheapest, and we do not pad a straightforward product with work it does not need. We define the scope that matches your product’s real regulatory risk, price it fairly, and stand behind it with experienced, independent toxicological judgement drawn from regulatory submissions and deficiency work across many clients, regulators, and industries. That judgement is what gets the scope right the first time, flags formulation and exposure risks early, and keeps avoidable questions and delays off your critical path.