Optimize Clinical Research
With Cutting-Edge Risk-Based Monitoring and Auditing Solutions
Explore More
End-to-end global regulatory partner
Strategy > Submissions > Lifecycle Management
Explore More
Evaluate standard consulting service
with our trusted GMP audit solutions
Explore More
Optimize Clinical Research
With Cutting-Edge Risk-Based Monitoring and Auditing Solutions
Explore More
End-to-end global regulatory partner
Strategy > Submissions > Lifecycle Management
Explore More
Evaluate standard consulting service
with our trusted GMP audit solutions
Explore More
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Our core capabilities

What’s we offer

Good Clinical Practice

Transforming Medical Innovations into Real-World Success with Expert GCP Services

We are a global leader in clinical trials, with over 19 years of experience delivering GCP-compliant services. Specializing in real-world evaluation of novel medical interventions, we provide end-to-end solutions covering planning, execution, monitoring, and reporting. Our expertise spans biomedical and behavioural research, ensuring safety, effectiveness, and regulatory compliance for therapeutic products worldwide.

Audit

Zenovel provides an opportunity to clients to choose a wide range of audits. We have a well experienced dedicated team of auditors.

Monitoring

Efficient Clinical Research Monitoring is critical for protecting the well-being of trial participants and maintaining the integrity of final results.

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.

Project Managing

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.

Good Manufacturing Practice

Global Experts in Quality Assurance, Compliance, and Operational Excellence with Tailored GMP Services

We are renowned for Good Manufacturing Practice (GMP) services for pharmaceutical and life sciences sectors, focusing on supply chain management, supplier qualification, and process optimization, ensuring compliance and quality from production to delivery.

Audit

Zenovel provides an opportunity to clients to choose a wide range of audits. We have a well experienced dedicated team of auditors.

Monitoring

Efficient Clinical Research Monitoring is critical for protecting the well-being of trial participants and maintaining the integrity of final results.

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.

Project Managing

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.

Good Manufacturing Practice

Global Experts in Quality Assurance, Compliance, and Operational Excellence with Tailored GMP Services

We are renowned for Good Manufacturing Practice (GMP) services for pharmaceutical and life sciences sectors, focusing on supply chain management, supplier qualification, and process optimization, ensuring compliance and quality from production to delivery.

Regulatory

Empowering Your Journey through Regulatory Landscapes

Regulatory Services AI-Driven Solutions for Seamless Regulatory Navigation

Utilize advanced technology to streamline compliance processes, improve accuracy, and expedite decision-making, ensuring your products meet global regulations efficiently and effectively.

During Submission Navigating the Submission Intricacy with Expertise

Providing expert support throughout the submission process to ensure all documentation is accurate, complete, and compliant with regulatory standards, thereby facilitating timely reviews and approvals.

Pre Submission Streamlining Submissions for Optimal Outcomes

Guiding companies through the complexities of submission preparation, ensuring compliance with regulatory requirements, and enhancing the likelihood of successful approval

Post Submission Ensuring Compliance after Submission

Offering comprehensive support post-submission to monitor regulatory feedback, address inquiries, and make necessary adjustments to ensure compliance and successful product launch

Pre-inspection
Readiness

Step 1
Smart Clinical Trial Design: Build the Foundation

Assists clients in designing scientifically robust clinical trials, minimizing complexity, avoiding costly protocol amendments, and ensuring smooth execution for faster results.

Step 2
Quality by Design: Build Quality in Process

Prioritize quality in clinical trial processes, collaborating with clients to define objectives, assess risks, and implement "Quality by Design" strategies for regulatory compliance and high-quality outcomes.

Step 3
Collaboration with Key Stakeholders

Promotes collaboration among cross-functional teams, investigators, vendors, and patient organizations, ensuring all perspectives are considered for efficient trials that align with stakeholder needs.

Step 4
Continuous Improvement: Learn and Evolve

Robustquality control systems, compliance checks, and independent audits assist clients in identifying areas for improvement, managing risks, and implementing corrective actions for efficient, high-quality trials.

Step 5
Promote a Culture of Quality

Fosters a quality culture within organizations through trust-building, critical thinking, and awareness training, motivating teams to consistently deliver top-tier performance and compliance.

Step 1
Execute Internal Audits

Performs regular internal audits to identify gaps, ensuring that all processes are GMP-compliant and ready for inspections.

Step 2
Set up a Robust Documentation System

Assist clients in creating and maintaining comprehensive, accurate documentation for easy access during GMP inspections.

Step 3
Effective Employee Training

Provides targeted training programs to ensure all staff understand and adhere to GMP guidelines, enhancing inspection readiness.

Step 4
Bring Quality Control Measures Into Practice

Implement strict quality control processes that ensure compliance with industry standards and regulatory requirements.

Step 5
Cultivate a Systematic and Sterile Facility

Ensures that clients maintain an organized, compliant facility, meeting all cleanliness and operational standards essential for GMP inspections.

Pre-inspection Readiness

GCP Step 1

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GCP Step 3

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GCP Step 2

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GCP Step 4

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GMP Step 1

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GMP Step 3

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GMP Step 2

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

GMP Step 4

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

Drug Development and discovery services

Unlocking New Horizons in Medicine from Target Identification to Clinical Trials

We offers comprehensive Drug Discovery services, leveraging advanced scientific and technological expertise to identify and validate drug targets, conduct medicinal chemistry, perform ADME-ToX studies, and evaluate pharmacological properties, all leading to effective preclinical development and formulation before clinical trials.

Chemistry Services

– Computational Chemistry
– Medicinal Chemistry
– Synthetic Chemistry (FTE/FFS models)
– Custom Synthesis (impurities/metabolites)
– Process development and CMC
– API development strategy
– GMP manufacturing of NCEs/APIs

Biology Services

– In vitro ADME
– In vitro Biology
– In vitro Toxicology
– In vivo DMPK
– In vivo efficacy
– Repeat dose toxicology

Formulation & Analytical

– Preformulation studies
– Development of solid, liquid, injectables and other dosage forms
– Stability studies as per ICH guidelines
– Analytical method development and validation
– GMP manufacturing of drug product

Training

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Training

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Training

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Training

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Our core capabilities

Training

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Sameera Sinha

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Sameera Sinha

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Sameera Sinha

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Sameera Sinha

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Sameera Sinha

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Why Zenovel

We are a team of experienced people

Tailored made service packages offered and make the trial cost effective

Ethics, quality and customer satisfaction is the prime focus in our mind

Well trained experienced staff dedicated for CGP, GMP and Regulatory services

Collective monitoring of approx. 700 study monitoring across globe

Our footprints on the world

Blogs and news

Our Latest Article

A Glimpse Inside

hey we are here

Upcoming Events

Take Your Business
Marketing Next Level

Elevate your brand with our Facebook Ads management service. We specialize in crafting targeted campaigns that drive engagement and sales.

Certification

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What Our Clients Say

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