Insights
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12 December, 2025 Pharmacovigilance ArticlesRisk Based Approach to Auditing in Pharmacovigilance
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08 December, 2025 Pharmacovigilance Articles
How to manage pharmacovigilance effectively in compassionate use programs
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05 December, 2025 Pharmacovigilance Case Studies
Case Study: Rapid Setup of Local Pharmacovigilance System in Europe
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04 December, 2025 Regulatory Affairs Articles
Electronic product information (ePI)
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03 December, 2025 Regulatory Affairs Webinars
Webinar- Navigating Compliance in EU: Ethical Interactions with Healthcare Professionals
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28 November, 2025 Pharmacovigilance Articles
From Fragmentation to Integration: A Strategic Review of Pharmacovigilance Systems Across LATAM
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24 November, 2025 Pharmacovigilance Articles
Pharmacovigilance Roles in Germany
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24 November, 2025 Pharmacovigilance Webinars
Webinar on Demand: Implementation of Educational Materials on a National Level in EU
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20 November, 2025 Pharmacovigilance Articles
Breaking Stereotypes of Local Literature Review
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19 November, 2025 Regulatory Affairs Articles
Structuring Local RA Outsourcing Projects the Right Way
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19 November, 2025 Pharmacovigilance Downloads
Educational Materials: Review of National Regulatory Requirements in the EU/EEA
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17 November, 2025 Pharmacovigilance Downloads
National Requirements for Local Person for Pharmacovigilance (LPPV) Nomination Across CIS and EAEU Countries
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11 November, 2025 Pharmacovigilance Webinars
Webinar “Pharmacovigilance System Transfer: Ensuring Seamless Shift”
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07 November, 2025 Pharmacovigilance Articles
Why an Integrated Safety Database Is Critical for Biotech and Pharma Success
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29 October, 2025 Pharmacovigilance Case Studies
Case Study: From Compliance Struggles to Confidence in Case Processing
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28 October, 2025 Regulatory Affairs Articles
Making Smarter In-Licensing Decisions
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27 October, 2025 Regulatory Affairs Articles
Choosing the Right Reference Member State for Your DCP
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17 October, 2025 Regulatory Affairs Articles
Dossier Gap Analysis: Ensuring Submission Readiness and Compliance
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14 October, 2025 Pharmacovigilance Articles
Pharmacovigilance System Transfer: How to Manage It Without Losing Control
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13 October, 2025 Regulatory Affairs Articles
Scaling Beyond Your First Market: Regulatory Pathways for Pharma Expansion into the EU
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10 October, 2025 Pharmacovigilance Downloads
National Requirements for Local Person for Pharmacovigilance (LPPV) Nomination Across MENA
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10 October, 2025 Regulatory Affairs Articles
Article 10a Bibliographic Applications: How to Build Them Right
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08 October, 2025 Regulatory Affairs Articles
Before You In-License: GMP Risks and Third-Country CMO Realities
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07 October, 2025 Regulatory Affairs Articles
Why Regulatory Intelligence Matters for Pharma: Different Needs for Small and Large Companies
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29 September, 2025 Pharmacovigilance Articles
National Requirements for LPPV Nomination Across CIS and EAEU Countries
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12 September, 2025 Regulatory Affairs Webinars
Webinar: Grace Period Requirements in EU
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08 September, 2025 Regulatory Affairs Articles
Marketing Authorisation Holder Responsibilities: A Practical Guide for New Entrants
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02 September, 2025 Regulatory Affairs Articles
Importance and Best Practices of Readability User Testing
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26 August, 2025 Pharmacovigilance Articles
Case Processing Strategy for Biotech: Outsourcing Doesn’t Remove Responsibility
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22 August, 2025 Regulatory Affairs Webinars
Labelling Exemptions and Foreign Language Packs in EU/EEA
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20 August, 2025 Pharmacovigilance Regulatory Affairs Articles
Pharmaceutical marketing. How to ensure compliance?
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19 August, 2025 Pharmacovigilance Articles
Requirements for Nomination of a PV Contact Person
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14 August, 2025 Pharmacovigilance Articles
Pharmacovigilance Regulations in France: Specifics You Need to Know
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13 August, 2025 Pharmacovigilance Articles
Why Tying Your Pharmacovigilance to Your Clinical CRO Is Riskier Than You Think
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11 August, 2025 Regulatory Affairs Articles
Nitrosamines – what you need to know and consider for new Marketing Authorisation Applications
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08 August, 2025 Regulatory Affairs Articles
Comparison of the CEP and ASMF Procedures
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06 August, 2025 Regulatory Affairs Articles
e-PI Pilot projects overview
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03 August, 2025 Pharmacovigilance Articles
Clinical Safety Management Plan and its Importance
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01 August, 2025 Pharmacovigilance Articles
Pharmacovigilance System Set-Up
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28 July, 2025 Pharmacovigilance Articles
Why Quality Matters: The Importance of High-Quality Case Narratives for Biotechs in Pharmacovigilance
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25 July, 2025 Regulatory Affairs Articles
Rx to OTC Switch – The ‘Must-Haves’ For Success
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23 July, 2025 Regulatory Affairs Articles
Why Affiliates Should Consider Regulatory Affairs Outsourcing
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18 July, 2025 Regulatory Affairs Articles
How HTAR Will Transform Drug Development: Opportunities and Strategies
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17 July, 2025 Pharmacovigilance Case Studies
Case Study: From Misalignment to Full Integration- A Pharmacovigilance System Transition Done Right
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10 July, 2025 Pharmacovigilance
Pharmacovigilance in Switzerland: Navigating Unique Regulatory Challenges
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09 June, 2025 Regulatory Affairs Articles
Grace Period requirements in EU/ EEA
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06 June, 2025 Pharmacovigilance Downloads
Checklist for Pharmacovigilance System Transfer
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05 June, 2025 Regulatory Affairs Articles
Common Variation Application Invalidation Reasons
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29 May, 2025 Regulatory Affairs Articles
Labelling Exemptions and Foreign Packaging in the EU/EEA: A Practical Guide for Regulatory Strategy
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26 May, 2025 Pharmacovigilance Regulatory Affairs Company news
Insuvia ISO 9001:2015 Recertified
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23 May, 2025 Pharmacovigilance Downloads
National Requirements for Local Person for Pharmacovigilance (LPPV) Nomination Across the EU/EEA
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21 May, 2025 Regulatory Affairs Downloads
Requirements for the Variation Implementation and Grace Period terms in EU/EEA
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15 May, 2025 Regulatory Affairs Articles
Marketing Authorization Transfer Considerations
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14 May, 2025 Regulatory Affairs Downloads
Checklist For Self-Assessment For NP/MRP/DCP Variations Submissions
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13 May, 2025 Pharmacovigilance Articles
Local Person for PV (LPPV) Strategy Considerations
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14 April, 2025 Regulatory Affairs Downloads
Preparing For HTAR: A Strategic Readiness Checklist
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09 April, 2025 Regulatory Affairs Articles
Navigating Labelling Exemptions: Strategies for Market Access (Part II)
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18 March, 2025 Pharmacovigilance Articles
Implementation of Educational Materials on the National Level
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04 March, 2025 Company news
Insuvia Ranks in FT1000 Fastest Growing Companies in Europe
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06 February, 2025 Pharmacovigilance Articles
ISO IDMP standards implementation. What should MAHs prepare for?
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05 February, 2025 Pharmacovigilance Articles
Czech Republic Pharmacovigilance Legislation Updates
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05 September, 2024 Pharmacovigilance Regulatory Affairs Company news
Insuvia’s New Look and Enhanced Website
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03 July, 2024 Pharmacovigilance Articles
Local Pharmacovigilance Specifics in the UK: Key Points for Compliance
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20 June, 2024 Pharmacovigilance Regulatory Affairs Company news
Insuvia Co-funded by European Uninion
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22 April, 2024 Regulatory Affairs Articles
Regulatory Insights: Navigating ASMF and CEP Procedures
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08 March, 2024 Pharmacovigilance Articles
ISO IDMP: EMA‘s Recommendations for Data Migration
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05 March, 2024 Pharmacovigilance Regulatory Affairs Company news
Insuvia Ranked as the #282 Europe’s Fastest-Growing Company
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12 February, 2024 Regulatory Affairs Articles
Agreements with Healthcare Professionals – Compliance Considerations
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01 February, 2024 Regulatory Affairs Articles
Navigating Labelling Exemptions: Strategies for Market Access (Part I)
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07 January, 2024 Pharmacovigilance Articles
Achieving Success in National Scientific Advice Procedures
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23 August, 2023 Regulatory Affairs Articles
Managing Supply Issues with Labelling Exemptions and Foreign Language Packs at National Level in EU/EEA
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11 May, 2023 Regulatory Affairs Articles
ISO IDMP: Current Status and Future Developments
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16 March, 2023 Regulatory Affairs Articles
Building a Culture of Quality and Safety: Deviation and CAPA Management
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08 March, 2023 Pharmacovigilance Regulatory Affairs Company news
Financial Times names Insuvia as One of Europe’s Fastest Growing Companies
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09 January, 2023 Regulatory Affairs Articles
EU Clinical Trial Information System (CTIS): Changes In Safety Reporting Requirements
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20 September, 2022 Pharmacovigilance Regulatory Affairs Articles
Educational Materials: Review of National Regulatory Requirements in the EU/EEA
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13 July, 2022 Pharmacovigilance Regulatory Affairs Articles
PV Regulatory Intelligence and its Growing Importance
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08 June, 2022 Pharmacovigilance Regulatory Affairs Articles
Product Launch in the EU: Regulatory Affairs Considerations
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06 June, 2022 Company news
Insuvia Becomes ISO 9001:2015 Certified
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11 May, 2022 Pharmacovigilance Articles
Managing Pharmacovigilance Data Migration
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22 April, 2022 Pharmacovigilance Articles
Difference Between Vaccinovigilance & Pharmacovigilance
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19 April, 2022 Pharmacovigilance Articles
Centralizing Safety Data Management
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04 November, 2021 Regulatory Affairs Articles
Regulatory Affairs Outsourcing Considerations
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18 October, 2021 Pharmacovigilance Articles
QPPV Outsourcing in EU/EEA and its benefits for MAH
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21 July, 2021 Pharmacovigilance Articles
Integration of Client-Vendor Pharmacovigilance Systems
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16 December, 2020 Pharmacovigilance Articles
BREXIT – Key Changes in the UK Pharmacovigilance System
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09 December, 2020 Company news
Insuvia is Opening an Office in London
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19 October, 2020 Pharmacovigilance Articles
Safety Data Exchange Agreement (SDEA)
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09 September, 2020 Pharmacovigilance Regulatory Affairs Company news
Insuvia Opens a New Office in Baku, Azerbaijan
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03 August, 2020 Pharmacovigilance Articles
Periodic Safety Update Report (PSUR) – an Overview
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03 August, 2020 Regulatory Affairs Articles
Bringing the Dossiers into Compliance in the EAEU
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02 August, 2019 Pharmacovigilance Regulatory Affairs Company news
“Insuvia” UAB European Union Funded Project
