Trans Sped is the first trusted service provider in Romania and is constantly maintaining a high level of quality for the services offered to its customers. We went through several certification processes that guarantee the quality of services offered to our clients in the best conditions.
We first received the ISO 9001 certification in 2004, lead by our desire to provide reliable services to our clients, at a competitive price.
ISO 27001, first received in 2008, was a priority for our company, as we wanted to assure our clients of the high regard in which we place informational security management.
The Trans Sped Certificates are included in the EU Trusted List, validating the signatures as qualified.
Recent changes to the SAFE-BioPharma PKI framework have made it the first and only service that enables digital signature validation in both the US and the EU at government-recognized levels of trust, as our Root CAs are published in SAFE-BioPharma Trusted List.
In accordance with the "Regulation (EU) No. 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93 / EC" (in short the eIDAS Regulation), service providers must be audited once every two years by an accredited European auditing firms, verifying the compliance of the services provided with the eIDAS requirements and the ETSI technical standards.
Trans Sped is the first provider in Romania to successfully complete such an audit so that qualified certificates and time stamps issued are recognized in all EU countries.
Trans Sped has the most important implementation of certification solutions of a Romanian organization, on the competitive market of the United States. Our certificates became an integral part of applications offered by Science Applications International Corporation-SAIC (www.saic.com).
The recognition of the quality of Trans Sped services and Technologies is the fact that its authority was cross-certified with the Federal Bridge of the US, which confers confidence on the electronic signature certificates issued by it to be accepted in relation to all U.S. government institutions.
By obtaining ISO 9001 certification, Trans Sped certifies the development, implementation and improvement of quality management systems. The standard is implemented since 2004.
ISO 9001 certification proves that Trans Sped assumes the following:
The ISO 27001 "Information Security Management Systems" certification was a priority for Trans Sped, being obtained in 2008, in the desire to guarantee to our customers the maximum security for the data obtained from them and compliance with all regulations. Trans Sped always efficiently and permanently allocates all the resources necessary to maintain the high level of security for all services offered.
Since 2011, Trans Sped has become a "green" organization that reduces its negative impact on the environment. The ISO 14001 - "Environmental Management System" ensures that the company is:
The "Occupational Health and Safety Management" certification complements ISO 9001 "Quality Management" and ISO 14001 "Environmental Management System".
Trans Sped has been certified since 2011. The certification focuses on continuous improvement integrating the company's processes into the Plan, Do, Check, Act loop.
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review by the FDA.
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which transmissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.
Use the links from this section to download legal documents regarding regulatory practices and other useful information.