Local Regulatory Affairs
We specialize in country-level regulatory affairs support and are equipped to fully replace or enhance local affiliate regulatory affairs and compliance functions.
Our Services
With a strong local presence in all key markets, we are perfectly positioned to assist clients at every stage of their product journey.
Our deep domain knowledge not only covers regulatory subjects but also includes a comprehensive understanding of country-specific regulatory, compliance, quality assurance, and market access frameworks, ensuring that our clients receive complete support from a single source.
- Health Authority contact
- Professional advice and regulatory consulting
- Local Regulatory Intelligence
- New product registration / marketing authorisation application
- Product life-cycle management / maintenance
- Artwork review & management
- Promotional Materials review and approval
- Market Access, Pricing and Reimbursement
- Healthcare Compliance management (interactions with HCPs, sponsorship disclosure)
- QA national support/contact (falsified medicines, stock level notifications, recall/quality issues, product quality complaints, GDP requirements)
![Insuvia local regulatory affairs](https://insuvia.com/wp-content/uploads/2024/08/gianluca-baio-23hZoRFAroY-unsplash-9-1024x612.jpg)
![](https://insuvia.com/wp-content/uploads/2024/08/Product-launch-related-regulatory-support.png)
![](https://insuvia.com/wp-content/uploads/2024/08/pharmacovigilance-823x1024.jpg)
![](https://insuvia.com/wp-content/uploads/2024/08/Productportfolio-acquisitions-support-Insuvia.png)
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New Product Registration / Marketing Authorisation Application
- National Scientific Advice
- Market-specific dossier review
- Local Regulatory contact/representative services
- National phase/labeling management
- Product Launch-Related Regulatory Support
- Product Life-Cycle & Compliance Management
- Product/Portfolio Acquisitions or Divestments Support
![Insuvia pharmacovigilance and regulatory services](https://insuvia.com/wp-content/uploads/2024/07/Group-2087326465-min.jpg)
![Insuvia pharmacovigilance and regulatory services](https://insuvia.com/wp-content/uploads/2024/07/Group-2087326465-min.jpg)
Facts & Figures
The Numbers Behind Our Success
- 0+ Artwork revised per year
- 0+ Local promotional materials revised per year
- 0+ MAHs represented in front of HAs
FAQ’s
Can't find your question? Contact us, we're here to help!
- What support can you provide with Promotional Materials?
- What additional local services do you provide?
- Is it mandatory to appoint a local Regulatory Affairs (RA) person in the EU?
- When is it possible to supply Centrally Approved Products (CAP) with foreign packaging?
- What should an MAH consider when planning a product launch in the EU?
- What are the Sunset Clause requirements for Non-CP products?
Contact