Regulatory intelligence and registration management system LICENSALE.COM®
plays an instrumental role in making reproductive diagnostic products for women available in multiple countries around the world.
The world’s No. 1 selling brand in home pregnancy and fertility tests is Clearblue®*, and behind it is a global leader in the research, design, production and supply of advanced consumer diagnostic products, SPD Swiss Precision Diagnostics GmbH (SPD).
SPD’s brands are familiar in many countries and are trusted for their accuracy and simplicity by women keen to know more about their reproductive health. SPD brands are acclaimed for their pioneering innovation, and Clearblue® was the first brand to introduce a one-step pregnancy test, a one minute test, a urine sample indicator, digitally displayed results and a Weeks Indicator feature. Supported by over 30 years of expertise, quality and innovation in consumer diagnostics, the Clearblue product range is built on a strong foundation of peer-reviewed science and consumer understanding and is renowned for delivering accurate information to consumers when they need it.
Challenges in the regulatory process before using LICENSALE.COM®
Prior to opting to use LICENSALE.COM®, the complexities in product registration that SPD had to overcome included challenges in identifying the regulatory process and timelines in countries in which it wanted to sell its products, developing an understanding of local labelling requirements and understanding acceptability of claims and local import/distribution arrangements from a regulatory perspective. Furthermore, it required advice regarding the need for Good Manufacturing Practice (GMP) inspections in some markets, managing regulatory documentation for each product it wanted to launch in new markets, fulfilling the requirement for a local entity to make regulatory submissions in many markets and dealing with language requirements for regulatory submissions.
Working with Arazy Group has helped SPD to overcome its regulatory challenges, and to date, using LICENSALE.COM® has enabled SPD to register a range of in vitro diagnostic (IVD) devices in several new markets. SPD is also using the system for further projects that are underway in additional markets.
Janice Jose, SPD’s Regulatory Affairs Team Leader for Whitespace Projects, said: “Advantages of working with Arazy Group include their expert knowledge of regulatory processes in many markets throughout the world and that they offer a dedicated Arazy Group Client Manager, acting as a single point of contact with whom we can discuss the progress of ongoing projects and raise any specific questions or concerns.
“Furthermore, documents uploaded to LICENSALE.COM® just once can be used to support multiple regulatory projects, saving us both time and effort.”
today to discover how LICENSALE.COM® could assist you in gaining access to markets in 100+ countries faster and more cost-effectively than ever.
* Based on international sales in nearly 20 countries compiled using independent market research data.