What do different vendors offer?

As a bare-minimum requirement you should obtain the following documents:

Current CVs of all members of the toxicology group that will be preparing and reviewing your health-based exposure limit (HBEL) monographs. While not an absolute requirement of the EMA HBEL guideline, it is recommended that at least one member of the toxicology team be DABT or ERT certified. This makes it easy for regulatory inspectors to determine if a person is “qualified” and able to oversee the more junior staff.

Current version of the company’s organizational chart (organogram) depicting the reporting structure of the toxicology group and any members of the quality team.

Do they have the technical and support staff needed to handle large orders of ADE/PDE monographs in a timely manner?

When a large order of ADE/PDE monographs is placed, it generally takes many internal team members to ensure that the order is processed smoothly, producing quality monographs that are delivered on-time. These team members can include:

Sales professionals to make sure that the order is properly quoted and that all client-required documentation (technical agreements, confidentiality agreements, purchase orders, tax-related forms) have been completed and returned to the client.

Project managers to ensure that the work is properly scheduled. that requisite timelines are followed, and that all CAS registry numbers for each HBEL monograph have been verified.

Qualified and experienced toxicologists to perform the process of preparing the HBEL monographs.

Quality personnel to ensure that all HBEL monographs receive a peer-review and quality review prior to being transmitted to the client.

And finally, administrative and accounting personnel to enter all HBEL monograph orders into a records management system so that it can be recovered for many years later.

Another quick way to vet the current staff members of a potential HBEL monograph contractor is to use LinkedIn and search for the company name, select the company name from the list, and then select “People” from the company profile menu. You will now have a complete listing of all current employees with the specific consulting company. For example, here is the team at Affygility Solutions’ LinkedIn company profile. Beware of toxicology contractors that throw around the word “team” but have no listing of specific employees on the About Us or Staff section of their website, you may just find yourself working with a team of one.

What is the policy on updates for previously purchased monographs?

The answer to question 1 (Q1) in the EMA HBEL Q&A states that “The toxicological or pharmacological data, on which the HBEL calculation relies, requires periodical re-assessment throughout a product’s lifecycle.”

What this means is that a HBEL monograph is not a static document, never to be changed. Just like any other document in a quality program, HBEL monographs require a periodic review and update. Prior to purchasing HBEL monographs from a toxicology contractor, you should get an understanding of what is the process for receiving these needed updates. How will you be notified of an update? What is the frequency of updates? Will you incur an additional charge for the updates?

What is their policy on post-purchase technical support?

Prior to selecting a toxicology contractor, the client should make a determination of what is the toxicology contractor’s policy of post-purchase support should technical questions arise during regulatory inspections or other audits. Will it be provided separately? At what rate? Or, will simple questions be answered without charge?

Do they have the basic elements of a Quality System in place and what proof can they provide to demonstrate this system?

As you know, at a minimum, a Quality System should have a quality policy statement, an organizational chart with assignment of responsibilities, initial and ongoing training requirements, and a corrective/preventative action program. Find out in advance what Quality System your toxicology provider has in place.

Do they have general and professional liability insurance with worldwide coverage?

While it is difficult to believe that any company would operate without basic general liability and professional liability insurance, there are many companies who do not have such coverage. As you know, most pharmaceutical companies have minimum insurance requirements for their contractors and require them to provide certificates of insurance prior to beginning work. Ask before getting started with any toxicology provider.

Do they have adequate administrative support?

Post-sale administrative support is an important, but often overlooked, need for many clients. Here at Affygility Solutions we spend a significant amount of time doing the following for clients:

Running reports for clients to determine their previously purchased HBEL monographs.

Ensuring that updates are delivered to the right individuals in your company in case there are staff changes.

Producing financial client account statements that are necessary for client financial audits.

Providing certificates of tax residency forms and 10F forms to foreign countries.

Retrieving, producing, and processing marked “paid” invoices.

Conclusion

While at first it may appear that selecting a toxicology provider is a simple task and that all providers are the same, there are many details that should be considered upfront in order to prevent wasted time and money. The initial cost of the monograph is only one consideration.