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Regulatory Case Studies: ArisGlobal’s Collaborative Approach Helps Global Pharma Track Registrations

Customer Background

This European international pharmaceutical company engages in the research and development, production, marketing, and sale of drugs for the treatment of diseases of the nervous system. The customer has international production facilities in Europe and South America and affiliates or sales offices in more than 50 countries. It employs over 5000 people globally and its products are sold in more than 100 countries worldwide.

Business Challenges

The customer had a home grown product database which was based on free text. One of the prime concerns was that they couldn’t track anything based on free text. The existing solution was not reliable and needed reports which could not be created easily. While their home grown solution was simply a way for the headquarters to know its products globally, it did not help the organization reach its compliance or renewal goals for its products. The downside to not addressing this business challenge included regulatory warnings or possibly even fines and loss of brand reputation for the organization. Change was needed to increase efficiency and reduce risk.

Solution Selection & Implementations

The regulatory affairs (RA) department and headquarters held discussions to select a product for regulatory affairs to use to maintain and manage product registrations.
The customer put out a RFP for a regulatory affairs solution for which 3 vendors applied, including ArisGlobal. The process of selecting a solution was a collaborative one between regulatory affairs, IT and other departments in the organization. While pricing of the solution was an important factor in this process, it was more important to the customer to have a commercial off- the-shelf software solution (COTS) that would meet their needs with minimum required customization. The envisaged usage of the system required substantial tracking ability (which is included with ArisGlobal’s Register™ solution). Deep domain expertise in regulatory affairs and related areas was another important factor in the decision making process.

After a thorough RFP process, ArisGlobal was shortlisted along with two other vendors. Working with the company throughout the RFP process and really listening to them regarding their current and future customer needs (including showing them how ArisGlobal uses customer input to design future versions of solutions), helped establish ArisGlobal as a collaborative partner. The Register™ solution was selected as it fulfilled all the needs of the customer, enabling it to manage and track registrations worldwide in the most efficient way.

Business Benefits

Regulatory affairs has been able to align to business goals and provide up-to-date tracking information for the launch and renewals of all its products in all the countries in which is does business. The compliance risk has been addressed and there is a plan for ArisGlobal customers to ensure compliance even as regulations change and new ones (like IDMP), take effect.

Additionally the solution is now also used by numerous other functions in addition to regulatory affairs to capture and reference information. For example, manufacturing now uses Register to check specification title, document ID, country, and product when it makes a certificate of analysis for production. Register is also used to for approval of packaging material by the manufacturing function.

Quality control (QC) also utilizes Register to find information about packaging and form life form etc. The usage of the Register system by different functions within the organization are additional benefits to the customer.
After implementation the customer stated, “ArisGlobal listens to what we say and is responsive to our needs; we are happy with the system that has been provided by ArisGlobal.”

Perception among other Register users is that they like the system and would recommend it to other customers facing similar challenges. This customer was especially happy with the way ArisGlobal led the way with XEVMPD and had a roadmap addressing all relevant regulations. ArisGlobal had invested resources into XEVMPD up front compared to other vendors, and was doing so with IDMP, so they felt this was a relationship for the long-term.

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