Having and maintaining a strong global regulatory strategy and plans can help your organization not only stay in compliance but can be an integral part of corporate market growth strategies.
How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.
Before delving any further, let us make sure we are all using the terms "regulatory strategy" and "regulatory plan" in a similar way.
The benefits of developing and maintaining effective global regulatory strategies and plans are far-reaching. In addition to building a foundation for clear communication within the project team and with management, some of those benefits include:
To elaborate on my last point, the planning you do now can help save you from making an expensive mistake. For example, you don’t want to file for a market only to discover you don’t have the required information or learn it may be prohibitively expensive to get the Avoid this and other unnecessary costs by understanding early in the process which resources are necessary compared to the resources you have available.
An effective strategy or plan should be aligned with the business/marketing strategy for the product and the company. The strategy or plan must also have cross-functional buy-in from at least regulatory, marketing, product development, and executive management functions and must be feasible with the available internal and/or external resources. It is important to remember that no strategy or plan should be static. They should be updated as the project progresses or as conditions within the company evolve.
The strategy should include the following elements:
Elements of an effective regulatory plan include the following:
In order to accomplish cross-functional buy-in and to successfully develop and execute global regulatory plans, it is critical to establish interfaces and to define the roles of each function. All roles are responsible for clear communications across the project team and with management to ensure that any necessary adjustments can be made in a timely way. For example, the roles might look something like this, depending upon your organizational structure:
Now that you know how what elements belong in a global regulatory plan and strategy and understand how important cross-functional collaboration will be to your success, let’s address some common challenges that can arise.
Pressure to Get the Project Started
If you’re under a lot of pressure to get the project started, call a meeting with management and the project team. Remind everyone that investing time up front will save time later. Having adequate time ensures you can start with a draft of a plan and avoid hurried communication, which lead to significant delays.
It might be tempting to try and enter every market at the same time. But without a carefully considered plan, you will find there are insufficient resources to do the work and encounter significant time delays. As a result, product may never get cleared/approved or you will be unable to sell the product despite clearance/approval because of intellectual property (IP), reimbursement, trademark issues or other similar issues.
Unforeseen setbacks happen to everyone. Through a well-conceived plan, most setbacks can be avoided or handled quickly. Sometimes setbacks are inevitable, but you can get through them if you remember these three words: communicate, communicate, communicate.
Time and Cost Overruns
A well-conceived plan usually makes it possible to avoid time and cost overruns. When time overruns happen, try and get creative about how to get back on track. Maybe there is a resource that can help in the short term? Even with a plan in place, time and cost overruns sometimes happen, but you can work through them if you remember these three words: communicate, communicate, communicate.
Changes to the Regulations
It’s not uncommon for regulations to change, but you’re usually given a long lead time. It’s important that you stay abreast of regulations that can impact your business by subscribing to news that provides updates and/or subscribe to the FDA website. By staying informed, changes will never catch you off guard.
Difficulty with a Regulatory Agency Reviewer
First, it can always be helpful to establish a professional working relationship with the reviewer that engenders trust. As you work with the reviewer, follow these tips and the process will go as smoothly as possible.
At the end of the day, effective execution of global regulatory strategies and plans should save your company time and money and can often help you get product to the markets more efficiently.
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