Our Services
PHARMACOVIGILANCE SYSTEM SET-UP AND MAINTENANCE
At Navatio Pharma, we excel in developing and refining pharmacovigilance systems to ensure regulatory compliance and optimal safety monitoring. Our services include customized solutions for system setup, PSMF management, and SOP development, adhering to both US and European standards. We also offer expertise in crafting and reviewing standard operating procedures, alongside a flexible document management system designed to streamline and secure your processes. Partner with us to create a robust pharmacovigilance framework that keeps your system efficient and inspection-ready
GLOBAL AND LOCAL PHARMACOVIGILANCE ACTIVITIES
Navatio Pharma’s experienced team provides localized pharmacovigilance services, leveraging both in-house resources and local safety teams. Our services include:
Local services include
⦁ Local contact person
⦁ ICSR intake and local- case processing
⦁ Local literature reviews
⦁ Local submissions (such as aggregate reports, RMPs and ICSRs)
⦁ Compliance monitoring
⦁ Fulfilling local PV requirements in relevant procedures and systems
⦁ PV training
⦁ Regulatory authority inspections
⦁ Medical information services (link to MI services)
⦁ Translations
LITERATURE SURVEILLANCE
At Navatio Pharma, we provide specialized literature surveillance services as part of our comprehensive pharmacovigilance offerings. Our objective is to enable your organization to proactively monitor drug safety through meticulous analysis of published literature.
Our Literature Surveillance Service Include :
- Systematic Review of Scientific Literature
- Data Extraction and Reporting
- Risk Management Support
- Regulatory Compliance
SIGNAL MANAGEMENT
Effective signal management is essential for maintaining the safety and efficacy of your products. At Navatio Pharma, we provide expert signal management services to help you proactively identify, assess, and address potential safety concerns.
Our Signal Management Service Include :
- Signal Detection
- Signal Assessment
- Signal Validation
- Risk Assessment and Management
- Regulatory Reporting
- Ongoing Monitoring/li>
- Expert Consultation
PHARMACOVIGILANCE SERVICE : QPPV, DPO, LPPV, AND LP
Effective pharmacovigilance agreements (PVA) are crucial for defining and managing safety monitoring responsibilities between stakeholders involved in the development, distribution, and marketing of pharmaceutical products. At Navatio Pharma, we offer specialized services to help you establish, maintain, and optimize your pharmacovigilance agreements to ensure compliance and efficiency.
Our Pharmacovigilance Service :QPPV, DPO, LPPV, AND LP Include :
- Qualified Person for Pharmacovigilance (QPPV)
- Data Protection Officer (DPO)
- Local Person for Pharmacovigilance (LPPV)
- Local Pharmacovigilance (LP)
AGGREGATE REPORTS
Comprehensive and accurate aggregate reports are crucial for assessing the overall safety profile of your products. At Navatio Pharma, we provide expert services to compile, analyze, and present aggregate safety data to ensure regulatory compliance and support informed decision-making.
Our Aggregate Report Service Include :
- Periodic Safety Update Reports (PSURs)
- Annual Reports
- Development Safety Update Reports (DSURs)
- Regulatory Submissions
- Regulatory Compliance
- Data Analysis and Interpretation
- Expert Review and Consultation
PHARMACOVIGILANCE AUDITS
Ensuring the integrity and effectiveness of your pharmacovigilance practices is essential for maintaining regulatory compliance and safeguarding patient safety. At Navatio Pharma, we offer comprehensive pharmacovigilance audit services designed to assess, enhance, and ensure the quality of your safety monitoring systems.
Pharmacovigilance Audit Services include:
- Comprehensive Audits
- Regulatory Compliance Evaluation
- Detailed Reporting
- Corrective and Preventive Actions (CAPA):
- Follow-Up and Support
- Risk Management Review
- Expert Consultation
PHARMACOVIGILANCE AGREEMENTS (PVA)
Effective pharmacovigilance agreements (PVA) are crucial for defining and managing safety monitoring responsibilities between stakeholders involved in the development, distribution, and marketing of pharmaceutical products. At Navatio Pharma, we offer specialized services to help you establish, maintain, and optimize your pharmacovigilance agreements to ensure compliance and efficiency.
Pharmacovigilance Agreement Service include:
- Agreement Drafting and Review
- Regulatory Compliance:
- PVA Management and Updates
- Training and Implementation
- Inter-Party Coordination
- Documentation and Record-Keeping
- Expert Consultation
VETERINARY PHARMACOVIGILANCE
Ensuring the safety and efficacy of veterinary products is crucial for protecting animal health and welfare. At Navatio Pharma, we offer specialized veterinary pharmacovigilance services to help you monitor, assess, and manage the safety of veterinary medicines and products throughout their lifecycle.
Our Veterinary Pharmacovigilance Services include:
- Adverse Event Reporting
- Signal Detection and Assessment
- Risk Management
- Regulatory Compliance
- Data Management
- Safety Review and Reporting
- Training and Support
- Expert Consultation
- Customized Solutions
MEDICAL INFORMATION SERVICES
Accurate and timely medical information is vital for making informed decisions and ensuring patient safety. At Navatio Pharma, we provide comprehensive medical information services to support your organization’s needs and enhance the quality of information available to healthcare professionals and patients.
Navatio Pharma’s medical information services include:
- Medical Inquiry Management
- Product Information
- Regulatory Compliance
- Safety Information Management
- Clinical Trial Support
- Training and Support
- Medical Literature Review
- Customized Reporting
- Expert Consultation
COSMETOVIGILANCE
Ensuring the safety and efficacy of cosmetic products is essential for protecting consumer health and maintaining regulatory compliance. At Navatio Pharma, we provide specialized medical cosmetovigilance services to monitor, assess, and manage the safety of cosmetic products throughout their lifecycle.
Our Cosmetovigilance Services Include:
- Adverse Event Reporting
- Signal Detection and Assessment
- Risk Management
- Regulatory Compliance
- Safety Data Management
- Safety Review and Reporting
- Training and Support
- Expert Consultation
- Customized Solutions
RISK MANAGEMENT AND RISK MINIMISATION ACTIVITIES
Effective risk management and risk minimization are essential for maintaining the safety and efficacy of your products. At Navatio Pharma, we provide comprehensive services designed to identify, assess, and mitigate risks, ensuring the continued safety of your products throughout their lifecycle.
Our Risk Management And Minimisation Service Include :
- Risk Assessment
- Risk Management Plans (RMPs)
- Risk Minimization Strategies
- Safety Action Plans
- Regulatory Compliance
- Ongoing Monitoring
- Training Support
- Expert Consultation
MEDICAL WRITING SERVICES
At Navatio Pharma, we provide comprehensive medical writing services tailored to the needs of the pharmaceutical, biopharmaceutical, and medical device industries. Our experienced team specializes in crafting high-quality documents that meet regulatory standards and support your research and development efforts.
Our Medical Writing Services Include:
- Clinical Study Protocols
- Clinical Study Reports
- Regulatory Submission Documents
- Manuscripts and Publications
- Patient Information Leaflets
REGULATORY AFFAIRS SERVICES
At Navatio Pharma, we offer specialized regulatory affairs services to effectively manage the complexities of compliance within the pharmaceutical, biopharmaceutical, and medical device sectors. Our dedicated team is committed to ensuring that your products meet all regulatory requirements, facilitating a streamlined path to market.
Our Regular Affairs Service Include :
- Regulatory Strategy Development
- Submission Preparation
- Regulatory Intelligence
- Labeling and Advertising Compliance
- Regulatory Compliance
- Post-Market Surveillance
