Global platform-and-hub regulatory outsourcing service
All life sciences companies face a growing need to improve the ways they update and share regulatory information on a global scale. They are also under increasing pressure to streamline processes and improve the performances of in-country operations and partners. “The cost of maintaining head count for regulatory activities in smaller, less-strategic markets has become unsustainable,” says Adam Sherlock, ProductLife Group’s CEO. “If you’re using affiliates, the picture becomes even more complicated, making it difficult to gain the scalability, transparency, and standardisation companies now need.”
Until now, companies have had only limited options because outsourced services have been patchy – something ProductLife Group (www.productlifegroup.com) has set out to change. Earlier this year, a major industry debate the firm hosted on the subject confirmed that attitudes towards outsourcing are changing based on rising pressures. To help ease the administrative burdens on the industry, ProductLife Group, has continued to expand the firm’s global platform-and-hub-based regulatory outsourcing service.
The platform-and-hub-based service offers to relieve local operations from all regulatory information preparation and processing and from dealing directly with national authorities, which will free up in-country teams to focus on strategic and commercial roles.
Qualified local regulatory affairs resources are available in markets across Europe, the Middle East, Asia Pacific, Africa, Latin America, and North America; and ProductLife Group’s geographic reach continues to lengthen. Support for each country is provided either through ProductLife Group’s own people or through local, vetted partners. “We’re offering life sciences companies the best of both worlds: global scope and economies of scale, complemented by in-country expertise. Effectively, we can act as the operational back office for all regulatory maintenance activities at the local-affiliate-company level – worldwide. This framework enables companies to streamline their processes and to consolidate and better deploy strategic resources in major markets,” says Sherlock.