“We have been seeing increasing demand for quality, regulatory and information management in our customer base. We were looking for a partner who has such a system, integrated with our eCTD submission solutions.” said Remco Munnik, Regulatory Information Director at Asphalion. “Several new regulations are coming into effect in Europe, for example the MDR on the medical device side, putting more controls around the quality, regulatory and clinical processes. With Agatha cloud-based solution, we are confident to sell this first-class leading product in Spain to meet our customers’ demand to improve the management of those processes. This partnership will strengthen our position as a market leading provider for Regulatory Information Technology systems and services in Spain.”
Asphalion provides a global range of services from early development, throughout the registration, until marketing and post-commercialization phases of its client product, leveraging a network of hundreds of regulatory experts. Asphalion´ s services are provided to Pharma, Biotech and Medical Devices companies worldwide, which is the target market for Agatha Cloud Services.
“This partnership with Asphalion allows us to bring our market leading cloud solutions to pharmas, biotechs and medical devices organizations in Spain, with implementation services and after sales support in Spanish,” says Guillaume Gerard, Chief Operating Officer at Agatha. “Asphalion strong business expertise coupled with Agatha immediately available standard modules for quality, regulatory and clinical management will help clients in Spain to easily ensure their compliance and streamline their document management and quality processes. We are very excited about this strategic partnership.”
Agatha Inc. is a leading strategic software solutions provider to the health care and life sciences industry, dedicated to helping the world’s hospitals, biotechnology, pharmaceutical, contract research organizations and medical device firms optimize the management of their Quality, Regulatory and Clinical documentation and processes.
More about Agatha at Agatha’s website (https://en.agathalife.com)