SERVICES

With its extensive skills in the fields of regulation, software engineering and pharmacovigilance, AB Cube supplies the necessary synergy for any project involving the implementation, standardization, and rationalization of your information exchanges.

Information-system consulting, and identification of the solutions best suited for your company in terms of electronic transmissions, ICSR, MPR, etc.

Implementation of e-transmission for ICSRs (EudraVigilance Estri-Gateway tests; E2B tests, etc. ).

Regulatory procedures: CNIL; MedDRA, etc., and filing with relevant authorities (EMEA; AFFSSAPS, etc.).

Consulting and auditing: preparation for inspections, verification of the regulatory compliance of your information and pharmacovigilance systems, etc.

Specific parameterization of existing pharmacovigilance software.

Bringing non-compliant E2B systems up to a state of fully-compliance.

Backlog management.

Assistance with EVMPD data entry..