How to Create an Effective Global Regulatory Strategy and Plan
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.
- Regulatory Strategy: Aligns the regulatory activities required to bring a new or modified product to market with the business or marketing strategy. It provides overall direction to the team by identifying the important regulatory elements.
- Regulatory Plan: Describes specific steps and action required to meet the regulatory strategy objectives. It contains the specific elements required to assemble the regulatory submissions.
Navigate Common Challenges
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.
Scattered Approach
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
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.
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