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Expertise & knowledge

Established in 1991


Services

RCAPharma, S.L. was founded in 1991 to offer expert support in regulatory affairs, pharmacovigilance and market access/P&R to pharmaceutical companies to introduce their products in the Spanish market

Pharmacovigilance

RCAPharma offers customized pharmacovigilance services to helps to fulfil national and European requirements in the most satisfactory way.

Pharmacovigilance has grown more and more important in the last few years.

Contact us
  • Local Responsible of PhV according to current Spanish regulations.
  • Global support 24 hours / 365 days.
  • Preparation and submission of Periodic Safety Update Reports (PSURs).
  • Literature Research.
  • Continuous surveillance of safety Alerts and Information in Spain.
  • Pharmacovigilance training.
  • Management, processing, evaluation and exchange of ICSRs.
  • National transmission of ICRS through FEDRA system for companies not performing electronic transmission.
  • Follow-up information on Spanish cases.
  • Monthly Reconciliation.
  • Pharmacovigilance System Master File (PSMF).
  • Tailor-made Pharmacovigilance SOPs.
  • Preparation, maintenance and management of Risk Management Plan (RMP).
  • Coordination with authorities and implementation of Educational Materials.
  • Quality Assurance and Audits.
  • Medical Device vigilance.
  • Medical Information Services.