Milano – December 11, 2019 – The Food and Drug Administration (FDA) has recently finished to test and just approved one of Intesi Group’s digital certificates service as being compliant with the requirements for Electronic Submission Gateway (ESG).
The digital certificates are compliant with FDA 21 CFR Part 11 and Drug Enforcement Administration (DEA) requirements for high level assurance of identity, assuring the non-repudiation of transactions.
With this new service, Intesi Group is helping life science companies communicate with the FDA and exchange electronic submissions.
With over 21 years of experience in providing state-of-the-art solutions for highly regulated industries, such as financial, life sciences and health care, Intesi Group is able to support enterprise-wide digital transformation. Our experts with solid backgrounds in advising biopharmaceutical companies can transform businesses to fully digital environments, addressing global regulatory requirements for digital identities and digital signatures in electronic transactions.
“As biopharmaceutical companies are putting their efforts in bringing to the market new drugs that can save lives, it is crucial that sensitive data be protected and exchanged in a secure way. We, at Intesi Group, understand the challenges this industry is facing and can offer solutions designed to improve efficiency and reduce complexity, staying compliant at the same time.
Our vision for 2020 and beyond will focus on access, quality, mobility and security for interoperable IT systems. Interoperability and API integration in patient medical records from clinical trials or health care are foundational for the ecosystem of patients, providers and pharma. Therefore, we are committed to offering tools and infrastructure for handling data in a secure way, preserving at the same time a retail-like buying user experience as the market demands” – Paolo Sironi, CEO Intesi Group.
Intesi Group has been on the market since 1998, providing highly technological products in the field of digital signatures, digital transactions management, cryptography and advanced cloud solutions. An innovative and unconventional approach to tech solutions in order to revolutionize the market of logical security, digital signature and encryption, became our benchmark. Intesi Group mission is to build a better and safer tech world.