March 11, 2016 / Andrew Brown

Streamline the Regulatory Submissions Process

Companies that operate in different countries have to comply with many different and sometimes inconsistent regulations. Good product stewardship can help mitigate the risks associated with regulatory compliance and prevent supply chain disruption, loss of income, fines and prosecution.

To successfully navigate regulatory scenarios, product stewards must pay attention to details while streamlining the process as much as possible. “We really need to ask where can I find the synergies that help move registration more quickly and what are the quirks, if any, that could block the process,” says Kerrie Canavan, consultant at ERM. For instance, in one case an application package was ready for submission when Canavan discovered that the submission method had suddenly changed. “Knowing these things can possibly happen is something to keep in mind as a product steward, as the role and requirements develop,” she says.

At Stewardship 2016, Canavan will share her experience at navigating different regulatory processes during the presentation Which Regulation Fits Where? Challenges and Solutions in Piecing Together the Regulatory Puzzle​​. She’ll discuss how and when submissions under one law can be applied to other regulatory notification schemes.

One of Canavan’s tips is to start with the information you know is common to nearly all regulatory submissions. Specifically, begin categorizing regulatory submissions under broad headings to help subject matter experts in different jurisdictions speak a common language or at least have a common set of nomenclature when referring to regulatory topics. “Across multiple jurisdictions, you know what questions they’re going to ask to determine critical information: What’s the tonnage that you're going to import? Who are the legal entities? It’s these basic questions that are overarching that we constantly ask of the companies that are going to submit,” she says.

Andrew Brown

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