Our Services
SCIENTIFIC AFFAIRS
Our highly skilled and experienced consultants will help you to set-up the best practices for your products in order to meet the global and local regulatory requirements and ensure the drug safety.
Benefits of outsourcing our services:
- Lower costs and risks compared to entering the markets independently
- Flexible resource allocation according to your needs
- More focus on your core business activities
REGULATORY AFFAIRS
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PHARMACOVIGILANCE
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REGULATORY AFFAIRS
PRE-APPROVAL STAGE
SERVICES
SERVICES
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SERVICES DURING
SUBMISSION STAGE
SUBMISSION STAGE
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POST-APPROVAL
SERVICES
SERVICES
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PRE-APPROVAL STAGE SERVICES
- Dossier compilation
- Due diligence and strategy
- Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL) and labelling preparation
- Cooperation with EU agencies
- Support for local specific requirements
- Electronic Common Technical Document (eCTD)
Process Development and GMP Operations
- Dossier dispatch
- Submission of application
- Deficiencies management
- Local regulatory support/local representatives
- Translation of product information text
- Desktop Publishing (DTP) services i.e. mock-ups preparation and updates
- Report compilation and publishing
- eCTD import or baseline services
- Regulatory Information Management (RIM) data service
POST-APPROVAL SERVICES
- Portfolio management
- MA maintenance
- Reference Member State (RMS) transfers
- Industrial transfers support
- MAs harmonization strategy proposal and execution
PHARMACOVIGILANCE
Prague Scientific offers complete and compliant solutions for pharmacovigilance activities related to the detection, assessment, understanding and prevention of
adverse events or any other possible drug-related problems. Our consulting services cover all aspects of local pharmacovigilance in respective territories, which is
compliant with GVP (Good Vigilance Practices). Prague Scientific’s pharmacovigilance system is always prepared for audits and inspections, and it adapts to the latest demands for data security and business continuity. The system protects patients and includes a robust quality management that meets the standards of our partners.
Benefits of working with Prague Scientific:
• Comprehensive pharmacovigilance system
• Single point of contact for all markets
PRAGUE SCIENTIFIC OFFERS VARIOUS PHARMACOVIGILANCE SERVICES, SUCH AS:
• Local Pharmacovigilance contact points
• Management of safety information reports
• Local literature screening and regulatory intelligence monitoring
• Submissions and communication with local regulatory authorities
• Local adaptation and implementation of risk minimization measures
• Auditing of pharmacovigilance processes, auditing
• Comprehensive pharmacovigilance system
• Single point of contact for all markets
PRAGUE SCIENTIFIC OFFERS VARIOUS PHARMACOVIGILANCE SERVICES, SUCH AS:
• Local Pharmacovigilance contact points
• Management of safety information reports
• Local literature screening and regulatory intelligence monitoring
• Submissions and communication with local regulatory authorities
• Local adaptation and implementation of risk minimization measures
• Auditing of pharmacovigilance processes, auditing