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.

Our vision:

Helping our customers to achieve their up-to-date regulatory status according to the latest pharmaceutical trends

Our competences:

• Compilation and publishing electronic submission: eCTD or NeeS
• 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