We are what we repeatedly do. Excellence, then is not an act, but a habit.

Clinical Trial Information System (CTIS) has versatile functionalities, from managing different user roles, compiling clinical trial applications for new or updating ongoing trials, cross-referencing product documents in other clinical trials, receiving notifications & responding to requests for information, searching and accessing clinical trials, to recording of clinical trial results.

And we can support you to execute & govern ALL.

IRIS Platform facilitates the exchange of regulatory and scientific information between the European Medicines Agency (EMA) and organizations developing medicinal products for potential use in the European Union (EU). 

The following procedures are to be submitted with IRIS: Centralised Procedure (CP), Innovation Task Force (ITF) Office interactions, GxP Inspections, Orphan Drug Designation (ODD), Paediatric Investigational Plans (PIPs), Priority Medicines (PRIME), Scientific Advice (SA),  Small & Medium Enterprise (SME) Office interactions, CP Variations of all types etc. 

And we can support you to execute & govern ALL of them.

The Common European Submission Portal (CESP) provides a secure method of communicating with the EU/EEA National Competent Authorities (NCAs) via ONE platform, allowing the submission of ALL types of applications AT ONCE to all relevant NCAs. 

This reduces the burden of multiple submissions for both the industry and regulators. 

Nonetheless, there is still space for improvement and higher harmonization at the EU level toward full exemption of paper and national portal  CESP follow-up submissions.

However, we are experienced in the role of liaising with the authorities and can guide you.

 SPOR data management services are Substance (SMS), Product (PMS), Organisation (OMS) & Referentials (RMS) Management Services.

OMS and RMS are the first services to go live and they provide the data foundations for PMS and SMS.

Data management and data quality processes drive the SPOR data management services to ensure that the highest quality of data is available to support EU regulatory processes. 

We supported many companies in their journey to establish and maintain their  SPOR databases.

EUDAMED, the European Database on Medical Devices is one of the key aspects of the new rules on medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR).

EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU) integrating different electronic systems.

EUDAMED aims to enhance overall transparency, and to enhance coordination between the different Member States in the EU. 

We can be your EUDAMED guide.

The NextGen portal has been developed to improve submission processing and to foster interaction with developers of drug development tools. 

The Portal serves as a central location for submitting submissions, viewing submission statuses, and reviewing communications from the FDA. 

This is a common submission portal for all Drug Development Tool (DDT) electronic submissions including those that are CDER-specific, CBER-specific, or applicable across both Centers. 

Applications via the MHRA portal are for marketing authorization (MA), change of ownership of an MA, general product licensing submission (license cancellations, information updates, periodic benefit-risk evaluation reports (PBRERs), and various certifications), information submission for your MA, active substance master file for your product, application to renew your marketing authorization, variation application for MAs, & number allocation (PL XXX) as references for applications, and many other. 

And we can guide you through the MHRA Portal.