AnaCipher CRO services

  • AnaCipher CRO services 1
  • AnaCipher CRO services 3
Product Description

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AnaCipher Clinical Research

  • Country/Region:
    India
  • On CPHI since:
    2021
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Contract Service
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Categories
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Specifications
  • Selling Points
    Quality Service; we offer a comprehensive services:

    End to End BABE studies ,
    Medical Information Call Centre
    Individual Case Safety Reports (ICSR)
    Risk Management Signal Management
    Periodic Safety Update Reports (PSURs)
    Safety Data Management
    Qualified Person for Pharmacovigilance (QPPV) services for EU & UK
    Legacy Data Migration
    Marketing Authorization Holder (MAH) Support for PV Inspections and Quality Management System (QMS) Setup  Management Signal Management Periodic Safe...
  • Supplied from
    India
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Sales Markets
Show more Show less

AnaCipher Clinical Research

  • Country/Region:
    India
  • On CPHI since:
    2021
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Contract Service
View company profile

AnaCipher Clinical Research resources (1)

  • AnaCipher Clinical Research Organization

    Brochure AnaCipher Clinical Research Organization

    AnaCipher (CRO) BABE Centre holds approvals from the world’s leading regulatory authorities, including the USFDA, EMA, NPRA, WHO, UKMHRA and GCC (MOH - OMAN), in addition to local regulatory authority. Our Centre has successfully undergone seven FDA inspections without receiving any 483 observations, underscoring our commitment to the highest standards of quality and compliance. In 2023, we were inspected by EMA - Denmark & Finland, and in 2024 by WHO, both resulting in issuance of inspection closure letters. Recently March 2025, successfully completed USFDA inspection as well.

    Our key capabilities include:

    146-bed facility: Split into four independent Clinical Pharmacology Units (CPUs) for flexible and efficient study execution. Advanced Analytical Facilities: Equipped with 8 LC-MS/MS systems to support complex analytical requirements. Validated Methods – 250+ NABL...