5 Key Steps to Regulatory Strategy Development

By August 12, 2020January 22nd, 2021Blog
startup developing regulatory process

Building a regulatory strategy can be a highly taxing undertaking. However, it is critical for your product’s market success. It is advisable to build a regulatory strategy early in a new or modified product’s life cycle and appraise it periodically.

The global environment is becoming increasingly complex. Also, organizations do not rely on assumptions or duplicate former effective strategies anymore. Instead, companies are focusing on developing the most straightforward novel products. This means that startups must build customized regulatory strategies based on their short and long term corporate goals, the prevailing and future regulatory product development environment, and their stakeholders’ needs.

Check out these five key steps to creating a successful regulatory strategy.

Step 1: Recognize Product Attributes

Identify your proposed product’s attributes by assessing its design, use, and performance regulatory implications.

Start by creating open-ended questions to help your strategy building team identify and appropriately consider the factors that might have a regulatory impact on your business.

Other important factors to consider include the product’s features, substitutes, target markets, jurisdictional concerns, and post-market concerns.

Step 2: Perform Regulatory Intelligence

After successfully determining your product’s attributes, establish what prevailing regulatory precedents are likely to influence your regulatory strategy. Remember that even in the absence of a product that raises similar issues as yours, some analogous products, even those outside your specialty, can inform your regulatory strategy.

Step 3: Triangulate and Record

Critically evaluate your suggested product and triangulate the precedents you researched above. Establish the probable issues your product might raise and determine how to best counter them.

Step 4: Substantiate Your Strategy’s Viability

After drafting your regulatory strategy and documenting all the major assumptions and risks, invite the internal stakeholder team to ensure that the strategy mirrors the project’s goals and the product’s attributes.

Step 5: Update the Strategy

The regulatory environment evolves continually. So, you should stay up-to-date of the regulatory developments that might impact your project or product.

Furthermore, some internal change drivers like product design and features might require you to revise your strategy.

Contact Larta Institute Today!

At Larta Institute, we offer a plethora of services requisite to market excellence. If you’re searching for assistance in accomplishing your startup’s regulatory approval process milestones, contact us today! Our expert advisors will help you create an effective customized regulatory strategy.