QUALITY
COMPLIANCE
INTEGRITY
GCP
Complete guidance to risk based
monitoring approach
GMP
Wide range of GMP Audit services
REGULATORY
Expert regulatory service globally
Welcome to Zenovel
Years of Experience
With team of experts with more than 17 years of experience, Zenovel is an emerging global leader, focusing to provide one stop solution to pharmaceutical industry to help safe and effective medicine come in market with expertise in clinical research, GMP and Regulatory Affairs. Highly preferred partner for GXP and Regulatory services across the globe.
Good Clinical Practice(GCP)
Monitoring
Zenovel was with the approach of “blends quality with integrity” to provide assurance to compliance to all it clients with Risk based monitoring approach. Zenovel believes to be reliable eye of clients during the monitoring and understands quality requirement of client to achieve desired output.
Audits
Zenovel provides client an opportunity to choose wide range of audits. We have well experienced dedicated auditors team. Auditor has faced many regulatory audits from different regulatory agency and regulatory inspectors.
Project Management
Project Management involve end to end services which start from Site Identification, Feasibility, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Study from Start to end till Final Close out and report submission.
PK Stat
Zenovel offers complete support in PK stat which starts from Study Design finalisation to final review of PK stat report/SAS Out put.
Good Manufacturing Practice(GMP)
Audit
Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.
Consulting
Designing of Procedures and SOPs, WI, Policies, Forms, Formats,
GAP Review of Quality System and Support in Improving the Documentation System
Plant Setup & Upgradation
Conceptualisation
Facility Plan and Design or Layout
Total Engineering Support
Procurement Support
Regulatory
Regulatory Services
We provide expert regulatory consulting services for global markets particularly in EU and US.
Pre-Submission
Registration and self-identification i.e. D-U-N-S number, FEI number request.
During Submission
Expert help in addressing Regulatory queries and concern like RTR, Further information request
Post Submission
Post approval updates
Renewal of Dossier
Why Zenovel
Ethics, quality and customer satisfaction are the prime focus in our mind. Well trained experienced staff dedicated for CGP, GMP and Regulatory services. Collective monitoring of 700 study monitoring across globe. Expertise in wide therapeutic range & regulatory like EMA, USFDA, WHO, DCGI & more.
