Phagecon
Portuguese pharmaceutical consultancy founded in 2006 providing regulatory, pharmacovigilance, quality assurance, clinical trial, scientific/medical writing, translation, and training services. Operates from Lisbon with international activities and a multidisciplinary team (reported >40 staff) supporting product life-cycle needs for medicines, medical devices and other health products.
Industries
Nr. of Employees
small (1-50)
Services
End-to-end regulatory support including strategic MA planning, dossier preparation (CTD/neeS/eCTD), submissions, liaison with authorities, post-approval maintenance and product launch support.
Implementation and operation of compliant PV systems, QPPV arrangements, ICSR reporting, signal management, periodic reporting and PV-related audits.
QMS design and implementation, GMP/GDP compliance support, licensing preparation for manufacturers and distributors, and QP/technical responsible services.
End-to-end clinical operations including protocol writing, site feasibility, regulatory submissions, monitoring, data management, decentralised/hybrid trial support and CSR preparation.
Preparation of technical reports, clinical and non-clinical overviews, environmental risk assessments, readability testing and toxicological evaluations.
Regulatory-focused translation services using validated CAT tools, back-translation and medical validation by clinical experts to meet NCA requirements.
End-to-end regulatory support including strategic MA planning, dossier preparation (CTD/neeS/eCTD), submissions, liaison with authorities, post-approval maintenance and product launch support.
Implementation and operation of compliant PV systems, QPPV arrangements, ICSR reporting, signal management, periodic reporting and PV-related audits.
QMS design and implementation, GMP/GDP compliance support, licensing preparation for manufacturers and distributors, and QP/technical responsible services.
End-to-end clinical operations including protocol writing, site feasibility, regulatory submissions, monitoring, data management, decentralised/hybrid trial support and CSR preparation.
Preparation of technical reports, clinical and non-clinical overviews, environmental risk assessments, readability testing and toxicological evaluations.
Regulatory-focused translation services using validated CAT tools, back-translation and medical validation by clinical experts to meet NCA requirements.
Expertise Areas
- Regulatory affairs and MA submissions
- Pharmacovigilance systems and safety reporting
- Quality assurance and GMP/GDP compliance
- Clinical trial management and site support
Key Technologies
- eCTD and electronic dossier publishing
- Electronic ICSR reporting / EudraVigilance
- xEVMPD registration
- Risk-based monitoring
News & Updates
Summary article on the role and responsibilities of Quality Assurance departments and relevant references to EU GMP guidelines.
News item about reduced evaluation times for mononational clinical trials reported by the Portuguese medicines authority.
Regulatory notice defining reference countries for pricing authorisations and annual price review rules for 2026.
Summary article on the role and responsibilities of Quality Assurance departments and relevant references to EU GMP guidelines.
News item about reduced evaluation times for mononational clinical trials reported by the Portuguese medicines authority.
Regulatory notice defining reference countries for pricing authorisations and annual price review rules for 2026.