GCP Services

  • GCP Services 1
  • GCP Services 2
  • GCP Services 3
Product Description

We offer a range of GCP services, from monitoring to audits. Providing comprehensive GCP compliance services for the pharmaceutical industry is one of our specialties.

A.   Risk-Based Monitoring: 

✔ Risk-Based Monitoring for Bioequivalence/Bioavailability Studies (BE/BA Studies)

✔ Risk-Based Monitoring for Phase-I Studies.

✔ Risk-Based Monitoring for Patient-Based PK/PD Studies.

✔ Risk-Based Monitoring for Late Phase Clinical Trials (Phase-II, Phase-III, Phase-IV)

✔ Expert Monitoring for Bioanalysis (including In-Process and Retrospective)

✔ Expert Monitoring for PK-Stat (Pharmacokinetic Statistics)


B.      Audits: 

✔ CRO Qualification/Requalification Audits

✔ Pre-Inspection readiness Audit/Mock-Inspection

✔ For-Cause Investigative Audit

✔ Retrospective Study Data Audit

✔ QA Audit

✔ Investigator Site Audit

✔  Safety Assessment Audit
 

C.    Sponsor Oversight: Complete Management of BE/BA Studies/Trial Outsourcing.

✔ Pre-Study Support
✔ During-Study Support

✔ Post-Study Support


D.   Standalone FSP Services:

✔ Medical Writing Services

✔ Regulatory Approval Support

✔ CRC/CRA Support

✔ Data Management Services

✔ GCP/GLP Training

✔ Pre-Clinical Facilitation

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Zenovel

  • Country/Region:
    India
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Primary activities
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile
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Specifications
  • Selling Points
    Brand Name; Convenience; Experienced Technicians; Guarantee/Warranty; Quality Service; Reputation
  • Model
    Clinical Research/Trials
  • Supplied from
    India
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Sales Markets
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Zenovel

  • Country/Region:
    India
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Primary activities
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile

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