RegInfo - professional regulatory consulting
The outsourcing of Regulatory Operations became increasingly necessary in case of the pharmaceutical companies, regardless of size.
RegInfo is a professional consulting company for Regulatory Affairs and Regulatory Operations in Life Sciences sector.
Helping our customers to achieve their up-to-date regulatory status according to the latest pharmaceutical trends
Compilation and publishing electronic submission: eCTD or vNeeS
Creating eCTD baseline
Consultancy in vendor selection for new Regulatory systems during the complete life cycle of the medical product
Support of Regulatory Information Management (RIM), migration of tracking data and system implementation
Consultancy in implementation of EDMS
Data entry in Regulatory system
Consultancy in IDMP
Consultancy in Regulatory Affairs
Assistance with applications of marketing authorization in Hungary (national, MR or DC procedures) – new MA applications, variations, renewals, MA transfers, de-registration
Local pharmacovigilance representation