Owl Pharma
Owlpharma is a Portuguese pharmaceutical consulting company dedicated to providing specialized services across the entire lifecycle of medicinal and healthcare products. With a focus on innovation, quality, and client needs, Owlpharma offers services in Regulatory Affairs, Pharmacovigilance, Quality Assurance, Medical & Scientific Affairs, and GxP Audits. The company supports the pharmaceutical industry with a highly skilled team and advanced tools, aiming to ensure compliance and excellence in healthcare and pharmaceutical sectors. Owlpharma emphasizes a strong Quality Assurance department, with a comprehensive team of officers and managers committed to maintaining high standards and regulatory compliance. The company actively engages in training, events, and knowledge sharing to stay at the forefront of industry developments.
Industries
Nr. of Employees
medium (51-250)
Products
Automated literature-screening and safety-monitoring platform
Validated automated search and literature-screening platform designed to support pharmacovigilance activities by routinely delivering curated search results in line with regulatory expectations.
Audit report repository and supplier-audit planning platform
Online solution to locate existing audit reports, plan audits and request supplier audits to support supplier qualification and audit programme management.
Pharmacovigilance Services
Comprehensive pharmacovigilance services including adverse event management, literature monitoring, PSUR & RMP elaboration, and signal management.
Regulatory Affairs
Specialized regulatory affairs team handling the difficult and ever-changing legislative framework of the pharmaceutical sector.
Quality Assurance
Quality Assurance services to ensure customers' worldwide compliance with regulatory standards across the lifecycle of medicinal and healthcare products.
Audits
A solution for conducting audits all around the world, executed by qualified internal auditors with extensive auditing expertise.
Automated literature-screening and safety-monitoring platform
Validated automated search and literature-screening platform designed to support pharmacovigilance activities by routinely delivering curated search results in line with regulatory expectations.
Audit report repository and supplier-audit planning platform
Online solution to locate existing audit reports, plan audits and request supplier audits to support supplier qualification and audit programme management.
Pharmacovigilance Services
Comprehensive pharmacovigilance services including adverse event management, literature monitoring, PSUR & RMP elaboration, and signal management.
Regulatory Affairs
Specialized regulatory affairs team handling the difficult and ever-changing legislative framework of the pharmaceutical sector.
Quality Assurance
Quality Assurance services to ensure customers' worldwide compliance with regulatory standards across the lifecycle of medicinal and healthcare products.
Audits
A solution for conducting audits all around the world, executed by qualified internal auditors with extensive auditing expertise.
Services
Advisory services for regulatory strategy, dossier preparation, electronic dossier conversion and liaison with health authorities for human medicines and medical devices.
End-to-end PV services from system setup (PSMF, SOPs, QMS) to operational support covering case processing, literature monitoring, periodic safety reporting, signal management and QPPV provision.
Preparation and review of clinical and non-clinical documentation, CTD modules, product information texts, periodic safety reports, risk-management plans and scientific communications.
QMS implementation and support, SOP preparation, risk management, GxP training and inspection readiness for regulated operations.
Independent audits covering pharmacovigilance, GxP, GCP and regulatory compliance to qualify suppliers, CMOs, sites and contractors and identify improvement opportunities.
Technical support for GMP manufacturing including process validation, qualification, contamination control and structured technology transfer between sites.
Advisory services for regulatory strategy, dossier preparation, electronic dossier conversion and liaison with health authorities for human medicines and medical devices.
End-to-end PV services from system setup (PSMF, SOPs, QMS) to operational support covering case processing, literature monitoring, periodic safety reporting, signal management and QPPV provision.
Preparation and review of clinical and non-clinical documentation, CTD modules, product information texts, periodic safety reports, risk-management plans and scientific communications.
QMS implementation and support, SOP preparation, risk management, GxP training and inspection readiness for regulated operations.
Independent audits covering pharmacovigilance, GxP, GCP and regulatory compliance to qualify suppliers, CMOs, sites and contractors and identify improvement opportunities.
Technical support for GMP manufacturing including process validation, qualification, contamination control and structured technology transfer between sites.
Expertise Areas
- Regulatory strategy and dossier submissions (including eCTD)
- Pharmacovigilance system implementation and operations
- Signal detection and safety-signal management
- Medical and regulatory writing for clinical and safety submissions
Key Technologies
- eCTD electronic dossier format and submission builds
- Validated literature-screening and safety-monitoring systems
- Audit repository and supplier-audit workflow platforms
- Regulatory pharmacovigilance databases and submission systems (e.g., EudraVigilance/EVDAS, XEVMPD/Art.57, CTIS, IDMP/SPOR)
News & Updates
Event related to pharmacovigilance contracts, scheduled for November 12, 2025, online.
Event about health product advertising, scheduled for November 5, 2024, online.
News about new requirements for medicinal cannabis export/import, scheduled for June 16, 2025.
News about EMA's expectations, scheduled for April 22, 2025.
Event related to pharmacovigilance contracts, scheduled for November 12, 2025, online.
Event about health product advertising, scheduled for November 5, 2024, online.
News about new requirements for medicinal cannabis export/import, scheduled for June 16, 2025.
News about EMA's expectations, scheduled for April 22, 2025.