Accelerating Product Launch: How RegDesk Helped a Fortune 100 Company Introduce Two New Products in 18 EU & Non-EU Countries 11 Months Faster
Situation
A subsidiary of a Fortune 100 company aimed to introduce two pharmaceutical products used to catalyze healthy blood clotting after surgery across 18 European countries, some of which are members of the EU and some of which are not. The company had already received approval for its drugs from the European Medicines Agency (EMA) through the centralized procedure but needed to ensure no additional country-specific product requirements.
Objectives
The company needed to identify any potential country-specific regulations and requirements before introducing its drugs to the market. This would require a comprehensive gap analysis that could identify the regulations for each country in the target region.
Why They Chose RegDesk
The company had previously hired a U.S.-based consulting agency to investigate the protocols for each target country. However, this method increased the risk of inaccurate information.
RegDesk mitigated this risk by using its regulatory intelligence product to crowdsource the expertise of 54 vetted consultants across the 18 target countries. This ensured the company was presented with the most relevant and up-to-date information on national regulations for each country. In addition, engaging several in-country experts ensured that the client was presented with the most relevant information. Finally, highlighting areas of consensus and dissent among their opinions created a measure of reliability for each piece of information.
Results
The comprehensive report presented by RegDesk gave the company a clear picture of the regulations and requirements for each country in the target region. RegDesk’s crowdsourced and peer-reviewed gap analysis allowed the company to:
- Cut down its regulatory strategy timeline by 88%
- Reduce its regulatory risk by 75%
- Save them 11 months of time(as stated by their manager of regulatory affairs)
Summary of Challenges
- Need to identify potential country-specific regulations and requirements before introducing drugs to new markets
- Managing multiple countries within and outside the EU with different regulations and requirements
- Risk of inaccurate information
Summary of Results
- The company gained a clear picture of Regulatory Requirements for each country
- Reduced regulatory strategy timeline by 88%
- Reduced regulatory risk by 75%
- Saved 11 months of time
