Optimize Clinical Research

With Cutting-Edge Risk-Based Monitoring and Auditing Solutions

End-to-end global regulatory partner

Strategy > Submissions > Lifecycle Management

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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

Ensuring Compliance, Minimizing Risk for seamless clinical trials Conduct risk-based GCP audits for Phase I-III clinical trials, identifying potential areas of non-compliance to ensure regulatory adherence while optimizing organizational resources.

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Monitoring

Tailored Monitoring for Risk, Compliance, and Integrity in Every Trial Our approach aligns with ICH E6 (R2) guidelines, blending on-site and central monitoring tailored to trial-specific risks, ensuring subject safety and data integrity while meeting regulatory standards.

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Pre-inspection readiness

Empowering Your Inspection Readiness Through Comprehensive Preparation and Continuous Compliance Prepare you for inspections by organizing back-office operations, training interviewees, and assisting with real-time adaptations, while also supporting follow-up activities to promote compliance.

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Project Managing

Excellence in Project Management for Seamless Research Success Project management team handles setup, enrollment, operations, and reporting, utilizing tailored strategies to meet trial requirements efficiently, ensure regulatory compliance, and deliver high-quality results.

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Sponsor Oversight

Streamlining Clinical Trial Oversight for Ethical and Compliant Research Support sponsors to manage clinical trial oversight, comply with regulatory requirements, identify outsourcing opportunities, promote ethical conduct, and manage resources efficiently throughout the trial process.

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QMS Setup

Building Robust Quality Management Systems for Superior Performance Work for Quality Management Systems (QMS) enhancement for CROs, sites, and pharmaceutical companies, ensuring compliance with customer and regulatory requirements and improving operational efficiency through structured processes and defined responsibilities.

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PK Stat Review

Empowering your Research from Design to Review with complete PK stat support Render comprehensive support in PK statistics, from finalizing study designs to conducting thorough reviews, ensuring robust analysis and interpretation of data, enhancing research outcomes' integrity and reliability.

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CRO Setup / Upgradation

Enhancing Clinical Trial Management through Expert CRO Solutions Support in GCP-compliant setup and maintenance for CROs, vendor management, process optimization, QMS implementation, infrastructure development, and regulatory compliance, enhancing efficiency, quality, and regulatory adherence.

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CSV

Safeguarding your Success and Regulatory Compliance through Robust CSV solution Proficient in computer system validation (CSV) in compliance with regulatory requirements in pharma, biotech, and other regulated environments, ensuring critical details are addressed to prevent inspection issues and improve operational integrity.

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Training

Master Excellence and Equip Your Team with Tailored Training Guide and offer expert training modules to enhance Good Clinical Practices, covering essential topics that equip your team with the skills necessary for success in clinical research.

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Contract Staffing

Empowering Your Team with Skilled Contract Professionals Proffer contract staffing solutions for clinical research and pharmaceutical industries, offering flexible support, industry standards, operational efficiency enhancement, and access to a skilled pool of experts.

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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

Good Manufacturing Practice

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

Audit

Ensuring Compliance, Securing Quality with GMP Audits Our team of GMP consultants, auditors, and practitioners has been actively assisting pharmaceutical and medical device companies globally, providing expert supply chain quality assurance service.

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Consulting Services

Guiding You towards Sustainable Success Support in complete GMP consultancy services, providing strategic guidance on GMP compliance, process improvement, facility design, regulatory training, and expert support for product registration, qualification, and validation task

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Plant Setup/ Upgradation

Ensuring Compliance and Enhancing Facilities While Maintaining Continuous Production Ensure full GMP compliance for all manufacturing units while maintaining ongoing production, implementing upgrades, and meeting market demands without interruption through effective communication with clients.

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Pre-Inspection Readiness

Ensure Compliance before the Audit Guarantee your facility is fully prepared for regulatory audits by assessing processes, identifying gaps, and implementing corrective actions to ensure compliance and improve operational efficiency.

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Global Audit Library

Streamline Your Quality Assurance with Our Extensive Audit Repository Our extensive database provides access to vital audit resources, ensuring your organization stays informed and compliant with global regulatory standards, enhancing audit preparedness and streamlining quality assurance processes.

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QMS

Achieving Quality Goals through Customized Management System Our customized framework that integrates company objectives, quality policies, data management and client satisfaction to improve operational efficiency and ensure compliance, incorporating a quality manual, internal processes, regular evaluations, and detailed guidelines.

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CSV

Ensuring Compliance and Integrity in Every System Ensures computerized systems comply with regulatory requirements, maintain data integrity, and operational efficiency during validation, supporting ongoing compliance in pharmaceutical and biotech sectors through efficient implementation.

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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

AI powered regulatory Service 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.

Regulatory Compliance and GAP analysis Identify, Assess, and Achieve Compliance Success

Identify discrepancies in your processes, ensuring adherence to regulatory standards while optimizing operational efficiency for sustained compliance.

Pre Submission Regulatory Service 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

During Submission Navigating the Submission Intricacy with Expertise

Post Submission Regulatory Service 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

Regulatory Intelligence Service Navigating Regulatory Landscapes with Intelligence

Provides real-time insights and updates on global regulations, helping companies stay ahead of compliance requirements and make informed decisions throughout the product lifecycle.

Dossier In-Licensing Services Effortless Dossier In-licensing for Smooth Market Success

Streamline the process of acquiring regulatory dossiers, ensuring comprehensive evaluation and compliance with local and global regulations to facilitate smooth market entry.

Dossier Out-Licensing Services Maximize Your Product Potential Through Strategic Out-Licensing

Empower companies to strategically license their regulatory dossiers, maximizing product reach and revenue potential while ensuring compliance with all relevant regulations.

Due Diligence for Dossier Assistance Mitigate Risks with Expert Due Diligence for Dossier Management

Ensures thorough evaluation and validation of regulatory submissions, helping companies identify potential risks and opportunities before proceeding with licensing agreements

CTD Dossier Templates for US and EU Regulatory Authorities Simplifying Submissions with Tailored CTD Dossier Templates

Our CTD Dossier Templates are meticulously crafted to meet the specific requirements of US and EU regulatory authorities, streamlining the submission process and enhancing compliance for your product registrations

Biologic Registration Services Expert Guidance for Smooth Biologic Approvals

Ensure a streamlined process for bringing biologics to market, navigating the complexities of regulatory requirements while maintaining compliance and enhancing the chances of successful approvals

Batch Release and Batch Testing Site Support Elevating Standards in Batch Release and Testing

We guarantee product quality through rigorous testing and release protocols, ensuring regulatory compliance and optimizing efficiency before market entry.

Local QP Support for Batch Release in EU Ensuring Compliance with Local QP Support for Batch Release

Ensure your products meet EU regulations, promoting efficient market access, and provide expert oversight to ensure quality standards are met during the batch release process

Local QPPV Support Prioritizing Patient Safety and Compliance by Local QPPV support

Offers safety monitoring and compliance oversight, ensuring pharmacovigilance activities comply with regulatory requirements, improving patient safety and facilitating market access.

Electronic CTD Compilation Transforming Regulatory Submissions with ExperteCTD Services

Our services streamlines the submission process by ensuring regulatory documents meet electronic submission standards, compiling, formatting, and validating eCTDs for smooth review by regulatory authorities.

User Testing Services Ensuring Product Excellence through Rigorous User Testing

Ensure that our products meet user needs and regulatory standards, enhancing their usability, functionality, and compliance.

Bibliographic Application Elevate Your Submissions with Comprehensive Bibliographic Solutions

Streamline the process of gathering, organizing, and managing essential literature and references, ensuring comprehensive bibliographic data for well-supported submissions, enhancing the credibility and quality of documentation.

Regulatory Consulting/ Strategic Services Strategic Insights for Streamlined Regulatory Processes

We offer personalized guidance to companies to navigate intricate regulatory environments, assisting in developing effective strategies, enhancing compliance, and optimizing product development timelines.

Local Regulatory Partner for EU/ US Simplifying Your Regulatory Journey in the EU and US

Provide comprehensive knowledge of regional regulations, ensuring your products meet all necessary standards, thereby enhancing market access and operational efficiency.

Life Cycle Management Services Optimizing Product Performance by our Comprehensive Life Cycle Management

We offer comprehensive product support from inception to market withdrawal, ensuring compliance, optimizing performance, and enhancing product value throughout its life cycle, allowing for maximum return on investment and market adaptation.

Regulatory Staffing Services Tailored Staffing Solutions for Regulatory Success

We offer customized staffing solutions for organizations to navigate complex regulations, maintain compliance, and achieve business goals efficiently

CO/NCO Bridging Clinical and Non-Clinical Insights for Seamless Approvals

Offer a thorough evaluation of your product's safety, efficacy, and quality, ensuring regulatory compliance and a thorough understanding of clinical and non-clinical data.

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.