Audit

Audit
Product Description

Built as per ICH GCP E6 R2 and other international applicable regulatory standards. Highly customized to the scope of the audits across the therapeutic areas, phases of clinical trials, CROs and study size / complexity. Experience and well-regarded team including industry thought leaders. Includes audits for patients as well as healthy volunteers studies, system and QMS audit, due diligence and vendor qualification audit. 

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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
View company profile
Categories
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Specifications
  • Details
    Due Diligence Assessments, QMS Gap Analysis, Vendor Qualification Including CRO Audits. Site Audits, Pre-Inspection Audits and Post Inspection Assistance, Trial Master File and Other Document Review, GCLP Audits, CSV Audits.

  • Selling Points
    Quality Service; Reputation; Small Orders Accepted; Experience with one-on-one regulatory interactions, multiple markets, very high-quality deliverables. 100 % client recommendation for repeat services.

  • Model
    Onsite & Remote
  • Supplied from
    India
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Sales Markets
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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
View company profile

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ARKUS RESEARCH PRIVATE LIMITED resources (1)

  • Arkus Research Private Limited

    Brochure Arkus Research Private Limited

    Arkus Research is an India based service provider for Monitoring, Audits and Vendor Qualification for bioequivalence studies. Additionally, we provide Medical Monitoring, Support for regulatory queries and Document preparation (USFDA), QMS assessment and RWE strategy and solutions. The Arkus team is a well experienced team with a very sound understanding of operational and regulatory requirements of your studies.

    Reach out to us for compliant, effective solutions with a focus towards excellence.