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 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