Principia Biopharma
Sanofi is a global pharmaceutical company dedicated to developing life-changing treatments and vaccines for serious, chronic, and rare diseases. With over 100 years of experience, Sanofi plays a significant role in medical breakthroughs that save lives and improve quality of life. The company is committed to innovation, research, and making a positive impact on health and society worldwide.
Industries
Nr. of Employees
medium (51-250)
Principia Biopharma
South San Francisco, California, United States, North America
Products
National medicines registry and product index
Alphabetical public listing of marketed medicines with links to national regulatory registry entries and statutory product information documents (SPC/PIL).
Downloadable educational material collection
Collection of regulator-reviewed downloadable patient cards, prescriber guides and healthcare-professional materials in PDF format, plus related audio content where provided.
National medicines registry and product index
Alphabetical public listing of marketed medicines with links to national regulatory registry entries and statutory product information documents (SPC/PIL).
Downloadable educational material collection
Collection of regulator-reviewed downloadable patient cards, prescriber guides and healthcare-professional materials in PDF format, plus related audio content where provided.
Services
Adverse event intake and reporting service
Phone and email channels for submitting suspected adverse reactions and other safety information to local safety contacts, with guidance and escalation to national regulators.
Product quality defect reporting service
Channels for reporting suspected product quality defects and instructions for referral to regulatory authorities, supporting investigation and recall processes.
Public product information portal
Web portal listing marketed medicines with links to national regulatory registry entries, summaries of product characteristics and patient information leaflets to satisfy statutory public-information obligations.
Regulator-reviewed educational materials and downloads
Development, regulatory submission where required, and publication of downloadable educational resources for patients and healthcare professionals, including patient cards, prescriber guides and direct healthcare professional communications.
Regional clinical study coordination
Operational coordination and oversight of clinical studies conducted in the region, with links to public trial registries and local study contacts.
Data protection and privacy advisory resources
Publication of global and local data-protection policies, contact pathways for data-protection enquiries, and guidance on lawful processing, retention and subject-rights requests for HCPs and the public.
Adverse event intake and reporting service
Phone and email channels for submitting suspected adverse reactions and other safety information to local safety contacts, with guidance and escalation to national regulators.
Product quality defect reporting service
Channels for reporting suspected product quality defects and instructions for referral to regulatory authorities, supporting investigation and recall processes.
Public product information portal
Web portal listing marketed medicines with links to national regulatory registry entries, summaries of product characteristics and patient information leaflets to satisfy statutory public-information obligations.
Regulator-reviewed educational materials and downloads
Development, regulatory submission where required, and publication of downloadable educational resources for patients and healthcare professionals, including patient cards, prescriber guides and direct healthcare professional communications.
Regional clinical study coordination
Operational coordination and oversight of clinical studies conducted in the region, with links to public trial registries and local study contacts.
Data protection and privacy advisory resources
Publication of global and local data-protection policies, contact pathways for data-protection enquiries, and guidance on lawful processing, retention and subject-rights requests for HCPs and the public.
Expertise Areas
- Clinical trial management
- Pharmacovigilance and safety surveillance
- Regulatory compliance and public product information management
- Authoring and distribution of regulator-reviewed educational materials
Key Technologies
- Cloud hosting infrastructure for public web portals
- Web analytics platforms (traffic and performance monitoring)
- Cookie consent and preference-management frameworks
- Digital content management and distribution (PDFs, audio/podcasts)