GCP
GMP
Regulatory Affairs
Drug Dev. & Discovery
Key Expert Services
GCP

GCP

  • Audit
  • Risk Based Monitoring
  • Pre-Inspection Readiness
  • Sponsor Oversight
  • QMS Set up
  • Project Management
  • PK-Stat Review
  • CRO Setup & upgradation
  • CSV
  • Training
  • Contract Staffing
clinical research center​

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

GCP

  • Audit
  • Risk Based Monitoring
  • Pre-Inspection Readiness
  • Sponsor Oversight
  • QMS Set up
  • Project Management
  • PK-Stat Review
  • CRO Setup & upgradation
  • CSV
  • Training
  • Contract Staffing
GMP

GMP

  • Audit
  • Consulting
  • Plant Setup/Upgradation
  • Pre-Inspection Readiness
  • Global Audit Library
  • QMS Set up
  • CSV
GMP consultant

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Regulatory Affairs

RA Services

AI-powered Regulatory Affairs Services

Pre Submission Service

  • Regulatory Intelligence Services
  • Regulatory Compliance and GAP Analysis
  • Due Diligence of Dossier
  • Pre-submission services

Dossiers Related Services

  • CO/NCO
  • Dossier Templates (USA & EU)
  • Dossiers In Licensing
  • Dossiers Out Licensing
  • Bibliographic Application

Submission Services

  • eCTD compilation
  • Biologics Registration Services
  • Local Regulatory partner for EU/US

Post Submission Services

  • Lifecycle Management (LCM)
  • Post Submission Services

Batch Release & Testing Services

  • Batch release & batch testing site support
  • Local QP support for batch release in EU
  • User Testing Services

Support & Staffing Services

  • Local QPPV support (UK PL ES NL DE HR etc)
  • Regulatory Staffing Services

RA Services

AI-powered Regulatory Affairs Services

  • Ai Based Regulatory Services
  • Batch Release and Batch Testing Site Support Services
  • Bibliographical Application
  • Biologics Registration Services
  • Ctd Dossier Templates for The Us and Eu Regulatory Authorities
  • Dossier in Licensing
  • Dossier Out-Licensing
  • Due Diligence of Dossier Assistance
  • Electronic Common Technical Document Compliance
  • Life Cycle Management Services
  • Local Qp Support for Batch
  • Local Qppv Support Services
  • Local Regulatory Partner for Eu and Us
  • Post Submission Regulatory Services
  • Pre Submission Services
  • Regulatory Compliance and Gap Analysis
  • Regulatory Intelligence Services
  • Regulatory Staffing Services
  • Regulatory Consulting/Strategic services
  • User Testing Services
Drug Dev. & Discovery

Drug Dev. & Discovery

  • Chemistry services
  • biology services
  • formulation and analytical services
Drug Development

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Key Expert Services

Key Expert Services

  • IT-enabled services
  • Pre-clinical Support
  • Intellectual Property Services
  • Medical & Scientific Writing
  • Strategic and Business services
  • CMC Development
Pre-Clinical

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Services Overview
GCP
  • Audit
  • Risk Based Monitoring
  • Pre-Inspection Readiness
  • Sponsor Oversight
  • QMS Set up
  • Project Management
  • PK-Stat Review
  • CRO Setup & upgradation
  • CSV
  • Training
  • Contract Staffing
GMP
  • Audit
  • Consulting
  • Plant Setup/Upgradation
  • Pre-Inspection Readiness
  • Global Audit Library
  • QMS Set up
  • CSV
RA Services
  • Pre-submission services
  • Regulatory Intelligence Services
  • AI-powered Regulatory Affairs Services
  • Regulatory Consulting
  • Due Diligence of Dossier
  • Dossier Templates
  • Local Regulatory partner for EU/US
  • Batch release & batch testing site support
  • Biologics Registration Services
  • Regulatory Compliance and GAP Analysis
  • Local QP support for batch release in EU
  • Local QPPV support
  • Dossiers In Licensing and Out Licensing
  • eCTD compilation
  • CO/NCO
  • User Testing Services
  • Lifecycle Management (LCM)
  • Regulatory Staffing Services
  • Bibliographic Application
  • Post Submission Services
Drug Dev. & Discovery
  • Chemistry Services
  • Biology Services
  • Formulation and analytical services
Key Expert Services
  • IT-enabled services
  • Pre-clinical Support
  • Intellectual Property Services
  • Medical & Scientific Writing
  • Strategic and Business services
  • CMC Development