Pharmacovigilance

Pharmacovigilance
Product Description

Lambda provides end-to-end drug safety and pharmacovigilance support from clinical trials through post-marketing activities. Services include ICSR case processing and electronic submissions, aggregate reports, risk management plans, literature monitoring, signal detection and management, xEVMPD compliance, QPPV services, Local Responsible Person services, medical information, safety database support, PV consulting, quality management, compliance monitoring, and audit and inspection management. The organization supports drugs, vaccines, medical devices, biologics and biosimilars, combination products, and advanced therapy medicinal products. 

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Lambda Therapeutic Research Ltd

  • Country/Region:
    India
  • Founded:
    1999
  • On CPHI since:
    2015
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Clinical Research
Contract Research Organisation
Laboratory Services
Nutraceuticals
Regulatory Affairs
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Categories
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Specifications
  • Selling Points

    The organization operates PV functions across the UK, Poland, India, and Canada, with teams including physicians, pharmacists, and specialists supporting more than 400 active molecules. Lambda’s 2025 PV operations included more than 90,000 safety cases, 543,000 literature screenings, 1,282 signal management reports, 652 aggregate reports, and 225 risk management plans. With 30+ successful regulatory inspections of PV operations and experience across 400+ active molecules, Lambda provides regulatory-compliant pharmacovigilance support across drugs, vaccines, medical devices, biologics, biosimilars, combination products, and ATMPs.
  • Supplied from
    Canada; India; Poland; United Kingdom
More specifications Fewer specifications

Lambda Therapeutic Research Ltd

  • Country/Region:
    India
  • Founded:
    1999
  • On CPHI since:
    2015
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Clinical Research
Contract Research Organisation
Laboratory Services
Nutraceuticals
Regulatory Affairs
View company profile

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Lambda Therapeutic Research Ltd resources (3)