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 – UNITY™x and NOESIS
  • Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITY™dx
  • Clinical Documents Exchange Platform – UNITY™dx
  • Global & Local Literature Management Platform – UNITY™ai.Lit
  • Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx
  • 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- UNITY™dx
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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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Postmarketing Adverse Drug Experience (PADE) Inspections – Part I
Postmarketing Adverse Drug Experience (PADE) Inspections – Part I

Once a drug is approved, applicant holders MUST receive, evaluate, and report adverse drug experiences (ADEs) to FDA, even if…

Audits in Pharmacovigilance: A commitment to Safety
Audits in Pharmacovigilance: A commitment to Safety

In the realm of healthcare, ensuring patient safety is the most important aspect. That’s where pharmacovigilance plays a role in…

Causality Assessment in Pharmacovigilance
Causality Assessment in Pharmacovigilance

The causality assessment of adverse events, to determine the relationship or connection between the drug and adverse events, is an…

Pharmacovigilance for Decentralized Clinical Trials
Pharmacovigilance for Decentralized Clinical Trials

Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are…

Medical Literature Monitoring
Medical Literature Monitoring

The medical literature is a vital source of information for monitoring the safety and benefit-risk profile of medicinal products. It is…