CONTACT OUR SALES

90+

Regulatory Inspections supported by the team

483s

Critical or Major Inspection Findings

200+

Group employees out of 3 continents

50+

Clinical Trial Sites currently active on UNITYdx

350+

Molecules of Aggregate Reports

2,200+

Aggregate Reports for Submission in 65+ countires

50+

Active Clinical Trials

350+

Post-Marketed Molecules

180,000+

Annual Cases Medical Triage & Review

3,000+

Signalling Reports

>30%

Savings typically achieved through automation

99.99%

Submission Compliance

Soterius Expertise

We have a truly global presence capable of handling complete pharmacovigilance support and medical affairs across multiple geographies.

Clinical Safety Services

  • Clinical SAE Processing & Expedited Reporting
  • Medical Review of SAE
  • Medical Monitoring
  • Signal Detection & Signal Management
  • Development Safety Update Report (DSUR)
  • Reconciliation with Partners, Clinical Database
  • Responsible Person for Pharmacovigilance (RPPV)
  • CSR Narratives
  • Investigator Brochure
  • Global and Local Medical Literature Monitoring
  • Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections
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Postmarketed Pharmacovigilance Services

  • Case Intake, Processing, Submissions & Medical Review
  • Aggregate Reports – PSUR , ASR ,PADER , Report Calendar Management, Submission
  • Risk Management Plan (RMP), Risk Minimization, REMs
  • Global and Local Medical Literature Monitoring
  • QPPV, LSO & LRP Services
  • Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections
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Innovation & Technology

  • Hosted Drug Safety Database – ARISG, ARGUS
  • Integrated Medical Information, Product Complaints & AE Processing Platforms
  • Safety Case Intake & Case Processing Platform – UNITYx and NOESIS
  • Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITYdx
  • Clinical Documents Exchange Platform – UNITYdx
  • Global & Local Literature Management Platform – UNITYai.Lit
  • Collaborative Medical Writing with Generative AI Support Platform- UNITYdx
  • Managed Services, Hosting, Reporting for Drug Safety
  • Validation and CSV Support
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Medical Affairs and Medical Writing

  • Multilingual Global Medical Information Call Center
  • Developing & Managing FAQs and Standard Response Letters
  • Integrated Medical Information, Product Complaints & AE Processing Platforms
  • Developing Core Slide Decks
  • Systematic Literature Review
  • Posters and Abstracts
  • Collaborative Medical Writing with Generative AI Support Platform- UNITYdx
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Our Clients

Working with some of the Industry's Best

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What our client says?

CONNECT WITH US

Maria T. Castagna

Marketing Manager

Experts – with Services and Technology Offerings Head of Medical Affairs Division Top 5 Pharma

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Maria T. Castagna

Marketing Manager

Uber of Drug Safety Head of PV Global Pharma Company

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Maria T. Castagna

Marketing Manager

Cost-Effective through innovation, not just cost-cutting Board Member Top 10 Global Generic Company

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Maria T. Castagna

Marketing Manager

Re-Defining Pharmacoadherence Head of Global Medical Affairs Top 10 Global Pharma

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Culture at Soterius

People at Soterius

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Come Join us

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