Regulations. For those working with chemicals, compliance with regulations and appeasing their respective regulatory agencies is an ongoing and expensive part of today’s business world. Concerns over a chemical’s impacts on humans or ecological effects can compound a regulatory response and lead to the need for scientific studies. These studies may originate with the responding business or be requested from regulatory agencies, such as EPA, FDA, REACH, and PMRA, to fill in data gaps for chemical registration. As anyone who works within the regulatory world knows all too well, studies can quickly escalate in terms of time, effort, and, most notably for business, cost. Fortunately, there is a way to mitigate regulatory costs through an innocuously named and underused step: study management.

Savvy scientists and regulatory managers reduce their business risk (and headache) by employing study management practices while developing an overall regulatory strategy. This single decision can save a business significant money while preventing unnecessary delays, particularly when working in multiple locations and dealing with agencies globally. It may sound overly simple, but study management is more than monitoring work within a laboratory or out in the field; proper study management elevates the process to a strategic level by evaluating the need for data, identifying gaps within both the work and regulatory submittal, and determining if there is any supplementary information that can take the place of a laboratory study. It’s by identifying those gaps that study management creates the ability to negotiate agency waivers and prepare position statements, while saving:

Cost: Whether it is through successfully securing waivers or by avoiding duplicate or unnecessary studies, proper study management is a boon to the bottom line. An experienced study manager can look at the data and, much like a CPA poring over an individual’s taxes, find opportunities that will save money and streamline the submittal process. Should a study be warranted, having a study manager who has a finger on the pulse of laboratory availability, pricing, and expertise will save a business time and money during the data development stage all the way through to recommendations for study placement.

For example, the EU’s recent move to ban animal testing has impacted the pharmaceutical, veterinary sciences, health and beauty and many other industries. Without the use of laboratory animals, the question has been, “how are businesses going to introduce new chemicals/uses and show their new drug/products’ effects”? Our own study management team has been able to satisfy regulatory requirements by employing a combination of tools that have included literature reviews and evaluation of structural analogs through modeling. By combining available tools with strategically written positioning papers, no animals are harmed and viable compliance results are gained at a significant savings.

Time: As the saying goes in business, time is money, and the costs associated with long-term studies can quickly add up. An expert study manager can look at data and identify an opportunity to streamline or waive-off the regulatory request.

For example, let’s consider a manufacturer with an agency request for a 2-year, multi-generational fish study. The estimate for conducting this study is upwards of $500,000, not to mention the costs associated with the delay in getting their product to market. Rather than waste that time and money, our study managers suggested a QSAR model approach that can take the place of the laboratory study, saving $400,000 and 18 months’ worth of market delays. Had the manufacturer accepted the regulatory request on their own, they’d still be waiting to bring their product to market.

Impact to Registration: Study managers have expertise with difficult-to-test substances, acute and chronic toxicity, endocrine disruption, and environmental fate and metabolism studies ranging from screening-level tests to complex field study design. By leveraging this expertise, a study manager can eliminate or reduce the need for extensive studies while demonstrating compliance with the agency’s regulations.

Accuracy: Any proper study management should include an accuracy review where additional data gaps and unnecessary efforts can be identified. Through a critical review of the assumptions of exposure and physical-chemical properties leading to a requested study, study management can determine if any modification or specialized study design is needed or if the study can be bypassed altogether.

By strategically approaching the regulatory request at the onset, study management can ensure a business is in compliance without spending extra budget. Should an emergency arise, study managers can evaluate a submittal and identify then negotiate waivers with the respective regulatory agencies. This seemingly “extra” step, in actuality, saves wasted time and money in the long run.