Size Matters in Managing Regulatory Challenges

By Gary Charbonneau, Vice President Global Regulatory Affairs at Allergan

There’s no doubt that we, as an industry, all face similar challenges around regulatory submissions and getting a handle on our regulatory information. But the scale, emphasis, and needs differ quite significantly according to size, scope, and global reach.

For a company going from mid-tier to larger, from more narrowly focused therapeutically to having products in multiple therapeutic categories, and from being more locally based to having a global reach, the issues can be highly complex.

Some difficulties, for example, include safeguarding the secure exchange of data across a growing company, ensuring that information can be accessed by diverse groups in different geographies, tracking CMC information, and enabling seamless communication between partners.  This last issue can be a particular challenge given that each partner will likely have different systems in place. Not only is that a technical challenge but also requires getting buy-in from organizations with different reporting lines and structures.

System Stresses
Then there’s the issue of managing existing publishing systems, dealing with upgrades, and training people on new systems. And it’s not just publishing systems; it’s document management, archiving, and so forth. It’s also making sure that people in newly established markets have access to the information needed for the health authorities.

For companies that might be changing their therapeutic focus or making decisions around what to do with existing products generally, complexities can range from having the right information about products on the market in order to make informed decisions about what should stay, what should go, what should be expanded to new markets, or where products should be withdrawn.

In the midst of all these issues, a growing company will likely be looking for external help, but the shape and extent of that help may vary. Certainly at this stage, it would seem unlikely that many innovator companies would let go of products in development, but as established companies begin to weigh their options, the need for help in managing maintenance products – those that are in at least one or two markets – is likely to become greater.

Resources are growing scarcer, work is expanding, economic uncertainty continues, and regulators are demanding more. Regulatory Affairs departments will need some help some help, whether increased internal resourcing or outside spend with a reliable vendor partner. The greatest challenge is for Regulatory Affairs to communicate the increased complexities to executive management for the need to properly resource the function to the long-term benefit of the company. The questions, depending on size and scope of the product line, are how much, where, and when should that help be made available.