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Open Market: Creating a Clearing for Commercialization

Challenge

The patent life of a crop protection active ingredient (AI) had expired, giving an international company access to a generic molecule manufactured in China. Among the challenges facing the organization, however, was the potential cost of re-approval of the active ingredient in Europe.

Could there be a profitable payoff in pursuing product registrations—before re-approval of the AI—in order to tap into new market opportunities?

More importantly, could the company, with its limited resources, lack of in-house regulatory expertise and narrow window of opportunity, navigate a myriad of mandatory compliance and regulatory requirements in time?

Solution

At the outset, it was a matter of risk versus reward when the company asked Battelle for help in obtaining registrations in order to commercialize their product.

The Battelle team decided that the best and swiftest course of action was to develop a minimum work program to gain access to a complete European regulatory data package.

To start, Battelle translated and summarized client-provided data into a Good Agricultural Practices table. Then, using a variety of background materials (including the draft assessment report from the Rapporteur Member State), Battelle conducted a detailed data gap analysis. The Battelle team also challenged data-protection studies, replacing them with equivalent studies and conducting risk assessments to ensure safe use results.

Then, with regulatory authority feedback in hand, Battelle amended the work plan accordingly. Finally, the Battelle team filled in data gaps, as well as provided needed waivers and robust risk assessments. This data, along with a letter of access to vertebrate studies, supported the new product registrations in the European marketplace.

Outcome

  • Quickly delivered a viable work plan to the European regulatory authority
  • Amended required documentation for compliance
  • Successfully submitted complete data packages on both the AI and affected products
  • Cleared the way for product commercialization