What is Regulatory Strategy?

A regulatory strategy is a formal document that aligns regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements that need to be addressed in order to market the device.

A strategy begins with the collaboration of a cross-functional team to identify important questions about the product. Other considerations include the type of regulatory submission, device risks, and lifecycle considerations. Regulatory strategies should be living documents that are reviewed and updated as the project evolves.

Business Strategy and Regulatory Strategy

A business strategy is one of the foundations upon which successful product development is based. Conducting regulatory intelligence is crucial to obtain as much information as possible about the regulation of similar or related products.

The strategy must be validated with internal and external stakeholders, including agency personnel. Internally driven changes may sometimes be difficult for employees to adjust to, and there may be challenges in capturing new markets.

Why is Data Governance Framework Important Now?

Gathering Key or Significant Information

The first key point is the acquisition of information, i.e., researching governing bodies’ rules and regulations, and reviewing what industry thought leaders have published on a particular topic. Knowledge is power, and the more information obtained, the better decisions can be made.

Processing/Analyzing Information to Understand its Relevance

Another area to consider is the analysis of the information collected. Regulations and standards may vary from country to country, so it is essential to consider the global nature of regulations and their relevance to the product development process.

Developing a Regulatory Strategy

A regulatory strategy should be a living document that allows for flexibility, enabling continuous flow of the first two points. Adjustments should be made as the product development progresses and new regulations or insights emerge.