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

Read more Show less

Zenovel

  • IN
  • 2021
    On CPHI since
  • 1
    Certificates
  • 25 - 49
    Employees
Company types
Consultancy
Contract Service
Primary activities
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile
Categories
more categories Show less
Specifications
  • Selling Points
    Brand Name; Convenience; Experienced Technicians; Guarantee/Warranty; Quality Service; Reputation
  • Model
    Clinical Research/Trials
  • Supplied from
    India
More specifications Fewer specifications
Sales Markets
Show more Show less

Zenovel

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

More Products from Zenovel (2)

  • GMP Audit & Consulting Services

    Product GMP Audit & Consulting Services

    We aim to provide the most reliable and preferred service platform to pharmaceutical companies worldwide for R&D cycle, regulatory affairs, and GMP compliance with a higher benchmark of quality, integrity, and ethics.

    ...
  • Regulatory Support

    Product Regulatory Support

    Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
    ...