Combining the strengths of MAIN5 and Iperion Life Sciences Consultancy for the benefit of the European Pharmaceutical Industry.
MAIN5 and Iperion Life Science Consultancy entered into a strategic alliance to better serve customers within the field of implementation of Regulatory Information Systems, data management, project management and change management.
“As the pharmaceutical industry faces organizational, technical and coordination challenges in an ever faster changing regulatory environment, the combined expertise of our companies will allow our customers access to top expertise with optimal communication possibilities,” Gero Neidlinger, partner of MAIN5 and Frits Stulp, managing director of Iperion Life Sciences Consultancy explain.
„Implementation of new regulatory guidance and new systems requires effective change and project management involving all stakeholders. The real change in our industry can only be made by understanding the roles of both regulator as well as industry side (including marketing authorization applicant, holder, and clinical research sponsor) and addressing the needs of the process. By combining the power of interoperable data with compatible processes, a real benefit can be achieved for the patient, and this is where our joint ambitions lie,” says Frits Stulp. In addition, as IDMP data is cross-functional in various business areas and often distributed across different IT systems and even third parties, immense effort is required to identify and consolidate all IDMP-relevant information with most customers,” Gero Neidlinger adds.
IDMP requires sustainable master data management and intelligent networking of product information, IT systems and processes. The objective is a 360-degree all-round view of the product data with homogeneous terminology and structure that will pay off doubly in the course of digitization. Both consulting companies are specialists in the digital transformation of the pharmaceutical industry, which is under heavy regulatory pressure.
The implementation of the ISO IDMP is phased in the areas Substance, Product, Organization and Referential Data (SPOR). Based on standardized data, a reliable exchange of drug information will be made possible and global interoperability ensured. There are several questions to answer in the respective pharmaceutical companies: Who in the company cares for which data, when, and how? In addition, IDMP stands in the future between previously independent software solutions of the various business units and requires common interfaces. “The decisive factor is a strategically oriented roadmap for sustainable implementation in the affected business units. Only then can synergy effects be used,” conclude Frits and Gero.
About MAIN5 (www.main5.de)
MAIN5 was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.
About Iperion Life Science Consultancy
Iperion Life Science Consultancy is a provider of consultancy and services in the area of (regulatory) information management in life sciences with offices in The Netherlands, Spain and the USA. Our mission is to enable the life sciences industry and regulators to innovate, to improve business processes and to optimize the supply chain leading to faster and more efficient delivery of medicines (and its associated information) to health care professionals and patients. Through the delivery of consultancy services, Iperion helps organizations achieve an increase in interoperability, data consistency and regulatory compliance achieving increased operational effectiveness and reduced costs.