Eignapharma
Provider of services to pharmaceutical companies offering business development, pharmacovigilance, regulatory affairs and GxP compliance audits. Operates from offices in Barcelona (Spain), Hyderabad (India) and Porto (Portugal) and supports marketing-authorisation, safety-monitoring and quality/compliance activities for medicines, nutraceuticals, medical devices and related products.
Industries
Nr. of Employees
small (1-50)
Products
GxP Compliance Audits
Compliance audit services covering GxP regulations for pharmaceutical operations.
Servicios Regulatorios
Preparación, envío y mantenimiento de autorizaciones de comercialización en Europa y servicios de asuntos regulatorios farmacéuticos.
Asegurar el cumplimiento de la farmacovigilancia europea
Servicios integrales de farmacovigilancia outsourcing, soporte al sistema y servicios EU QPPV para asegurar el cumplimiento normativo en Europa.
Regulatory Affairs Services
Tailored regulatory affairs services provided by an experienced team listening to client needs.
Cumplir con las normas europeas GMP / GDP
Servicios de auditoría y consultoría de cumplimiento para asegurar las normativas GMP y GDP en la industria farmacéutica.
EU QPPV
Appointment of European Qualified Person for Pharmacovigilance.
GxP Compliance Audits
Compliance audit services covering GxP regulations for pharmaceutical operations.
Servicios Regulatorios
Preparación, envío y mantenimiento de autorizaciones de comercialización en Europa y servicios de asuntos regulatorios farmacéuticos.
Asegurar el cumplimiento de la farmacovigilancia europea
Servicios integrales de farmacovigilancia outsourcing, soporte al sistema y servicios EU QPPV para asegurar el cumplimiento normativo en Europa.
Regulatory Affairs Services
Tailored regulatory affairs services provided by an experienced team listening to client needs.
Cumplir con las normas europeas GMP / GDP
Servicios de auditoría y consultoría de cumplimiento para asegurar las normativas GMP y GDP en la industria farmacéutica.
EU QPPV
Appointment of European Qualified Person for Pharmacovigilance.
Services
Partner identification and matchmaking, licensing and co‑development agreements, contract development/manufacturing, API sourcing, market research and M&A support.
Design, implementation and maintenance of pharmacovigilance systems including QPPV services, PSMF and RMP authoring, signal management, ICSR handling and regulatory submissions.
Regulatory strategy, dossier preparation and submission (eCTD), support for national and European procedures, labelling and product information support, EDQM/CEP support and lifecycle management.
GMP (FDF & API), GDP and GVP audits; pre‑audit assessments, on‑site audit execution, gap analysis, CAPA planning and re‑audits; inspection preparedness support.
Partner identification and matchmaking, licensing and co‑development agreements, contract development/manufacturing, API sourcing, market research and M&A support.
Design, implementation and maintenance of pharmacovigilance systems including QPPV services, PSMF and RMP authoring, signal management, ICSR handling and regulatory submissions.
Regulatory strategy, dossier preparation and submission (eCTD), support for national and European procedures, labelling and product information support, EDQM/CEP support and lifecycle management.
GMP (FDF & API), GDP and GVP audits; pre‑audit assessments, on‑site audit execution, gap analysis, CAPA planning and re‑audits; inspection preparedness support.
Expertise Areas
- Pharmacovigilance system implementation and maintenance
- Regulatory affairs and marketing‑authorisation submissions
- GxP compliance auditing (GMP/GDP/GVP)
- Pharma business development and licensing
Key Technologies
- eCTD electronic dossier publishing
- Safety database submission systems (EudraVigilance/EVWEB)
- XEVMPD / Art.57 regulatory database maintenance
- Pharmacovigilance database and ICSR management systems