Pharmaceutical Innovation Services
Pharmaceutical Innovation Services, S.L. is a strategic consulting firm founded in 2009, providing fully integrated services throughout the entire drug lifecycle, including development, regulatory approval, post-market compliance, quality, pharmacovigilance, and regulatory compliance. They support pharmaceutical companies with expertise in new product development, regulatory affairs, manufacturing, quality assurance, pharmacovigilance, clinical studies, and more, aiming to enhance and innovate pharmaceutical development and ensure long-term success.
Industries
Nr. of Employees
small (1-50)
Pharmaceutical Innovation Services
C/ Luis Martínez Feduchi, 32, Ático A, 28055 Madrid, Spain
Services
Integrated support from concept through commercialization including supplier selection, formulation and analytical development, project management and regulatory strategy.
Regulatory strategy, preparation and submission of eCTD dossiers, scientific advice requests, gap analysis, and lifecycle regulatory maintenance.
Support for process scale-up, transfer of manufacturing and analytical methods to production sites, process validation and manufacturing troubleshooting.
Quality systems implementation, risk assessments (including ICH Q3D and nitrosamines), audit support, SOP/PNT preparation and GDP/BPD certification support.
Post-marketing safety monitoring, adverse event reporting, signal detection, benefit–risk assessments, PV audits and bibliographic searches.
Services for clinical study planning and execution including protocol development, patient-centric and decentralized trial approaches, and operational support.
Integrated support from concept through commercialization including supplier selection, formulation and analytical development, project management and regulatory strategy.
Regulatory strategy, preparation and submission of eCTD dossiers, scientific advice requests, gap analysis, and lifecycle regulatory maintenance.
Support for process scale-up, transfer of manufacturing and analytical methods to production sites, process validation and manufacturing troubleshooting.
Quality systems implementation, risk assessments (including ICH Q3D and nitrosamines), audit support, SOP/PNT preparation and GDP/BPD certification support.
Post-marketing safety monitoring, adverse event reporting, signal detection, benefit–risk assessments, PV audits and bibliographic searches.
Services for clinical study planning and execution including protocol development, patient-centric and decentralized trial approaches, and operational support.
Expertise Areas
- Regulatory strategy and eCTD dossier management
- CMC, scale-up and technology transfer
- Clinical trial design and clinical operations
- Clinical data management and electronic data capture
Key Technologies
- Electronic Data Capture (EDC) / eCRF
- Artificial Intelligence / Machine Learning
- Cloud-based data storage and analytics
- Blockchain for data integrity
News & Updates
An article discussing innovative approaches to streamline research processes and bring products to market faster.
An article on the transformation of the pharmaceutical industry and the importance of innovation.
Guidance on navigating strict regulations and ensuring compliance.
Insights into manufacturing processes and technology transfer.
The role of pharmacovigilance in ensuring drug safety.
An article emphasizing the importance of clinical data management in drug development.
An article discussing innovative approaches to streamline research processes and bring products to market faster.
An article on the transformation of the pharmaceutical industry and the importance of innovation.
Guidance on navigating strict regulations and ensuring compliance.
Insights into manufacturing processes and technology transfer.
The role of pharmacovigilance in ensuring drug safety.
An article emphasizing the importance of clinical data management in drug development.