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Regulatory Affairs
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Pharmacovigilance
Pharmacovigilance
Integrated Safety Management from Development to Market
Delivering end-to-end pharmacovigilance services to ensure the highest standards of drug safety and regulatory compliance globally.
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Local Affiliate Services
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Company
Company
Excellence in Pharmacovigilance & Regulatory Affairs
Superior quality pharmacovigilance and regulatory affairs services helping the pharmaceutical industry make safe and effective healthcare products available worldwide.

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
Insuvia pharmacovigilance and regulatory services
Insuvia pharmacovigilance and regulatory services
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
FAQs
Can't find your question? Contact us, we're here to help!
Can't find your question? Contact us, we're here to help!
Contact
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