Eureka BPO announces a trial launch of PHARDO system for NPO Petrovax Pharm LLC, Russia’s leading developer and manufacturer of innovative pharmaceuticals and vaccines. Within the project framework, the procedure of preparation and approval of registration dossier sections has been computerized and optimized to accelerate market launches of medicinal products.
Over the implementation period, the project stages have been completed as follows:
- Current registration dossier filing process has been reviewed and optimized;
- PHARDO system functionality has been adjusted to the company’s requirements;
- User training at the company’s sites has been performed.
As a result of computerization of business processes, a regulatory documentation library will be formed that will become a shared resource for all process participants; the document drafting and approval time is expected to be reduced by 40%. Importantly, the creation of a unified dossier is a cross-functional process that involves different corporate units such as manufacturing, quality, medical, and regulatory. The system is used by more than 70 NPO Petrovax Pharm’s employees.
«The PHARDO system was implemented together with Eureka BPO in a short period, in less than 9 months. During the trial period, the registration dossier document approval processes will be tested and adjusted for medicinal product registration in Russia, the EAEU countries, and abroad pursuant to the requirements of their respective regulatory authorities and legislation. For our company, this is the first project involving computerization of marketing authorization processes», said NPO Petrovax Pharm President Elena Arkhangelskaya.
Presently, data migration is performed. The system transfer to productive operation is scheduled for May 2017.
PHARDO system’s major advantages are as follows:
- Formation of a shared workspace for registration dossier operations;
- Structured keeping of documents associated with each dossier;
- Document version control and possibility of working with regulatory observations;
- Possibility of approving all registration dossier documents and materials directly in the system.