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 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