We are developers of specialized software for the pharmaceutical and medical industries.

A simple solution for generating a registration dossier in the e-CTD document format, in accordance with the Ukrainian specification of Module 1, accompanied by the necessary training and support.

The program provides generation, validation and submission of a registration dossier in the e-CTD format, entering the sequence of submissions in the chronology of events, life cycle management – responses to comments, changes and re-registration. A single tool for working in many markets: EAEU and EU (in development).

A pharmacovigilance platform for a company or group of applicants that covers all critical processes according to GVP requirements and allows for rapid scaling: from the tasks of a local contact person (ULOF, KLOF) to a system covering dozens of countries.

A single database provides for maintaining a register of medicinal products, collection and processing of adverse reaction reports, electronic data exchange in ICH E2B (R2)/(R3) formats, development of a pharmacovigilance quality system, signal management, support for monitoring literature and Internet sources.

A key tool for digitalizing the quality management system and document flow in production or warehouse according to GMP and GDP requirements, facility management and equipment technical condition control (technical supervision, verification, calibration, etc.).

The system includes technologies for mass digitization of paper documents, QR-marking of documents, facilities and equipment, supports QEP and compliance with 21 CFR Part 11.