About Zenovel

Zenovel is a global leader in providing affordable, innovative, and high-quality solutions to the pharmaceutical industry. With over 20 years of expertise

We focus on delivering a one-stop solution to help safe and effective medicines reach the market. Our services include GCP & GMP monitoring and auditing, Regulatory Affairs, Sponsor Oversight, QMS management, Training, Pre-clinical support, CSV, and drug development and discovery services.

Zenovel’s strength lies in its team of experts, who combine their knowledge, skills, and ethical commitment to client success. We value integrity, wisdom, and innovation—creating a dynamic approach to address healthcare challenges and regulatory complexities.

Embodies core values like integrity, wisdom, compassion, and generosity, ensuring our work
is grounded in ethics and client trust.

Reflects our commitment to constant improvement, innovation, and a forward-thinking
mindset. We are driven by knowledge, experience, and timebound commitments.

Through a combination of vertical integration & a proactive client-centric approach, Zenovel has built a reputation as a trusted partner in the pharmaceutical space. We offer tailored GCP & GMP services, regulatory support, & auditing for pharmaceutical development globally.

Pre-Clinical, BA/BE, Clinical Trial-
Monitoring/Auditing/Training/PK etc.

Audits of API, Excipients, finished products facilities, Greenfield projects of plant set up, GAP/ QMS Audits, Support in regulatory inspections

Dossier (CTD) Preparation and review, e-CTD and procedure management, Clinical & Non-clinical overview write up, User testing

Zenovel’s global network of auditors and consultants supports over 250 clients across 45 countries, helping them overcome regulatory challenges and reach their goals faster. By simplifying the complex regulatory processes, we allow our clients to focus on what truly matters—bringing safe, effective treatments to patients in need.

“At Zenovel, we believe in going beyond compliance. Our philosophy centers on innovation, collaboration, and ethical integrity. We don’t just offer services; we deliver solutions that make a real difference in advancing healthcare. By simplifying regulatory complexities, we empower our clients to focus on innovation, ensuring safe and effective treatments reach patients. As we continue to expand globally, our unwavering commitment to ethics and quality drives us forward, making a meaningful impact on healthcare around the world.”

At Zenovel, we strive for “quality beyond compliance”. This means we don’t just meet the industry’s
regulatory standards; we consistently aim to exceed them. Our focus is on delivering the highest level of
excellence in GCP, GMP, and regulatory services. We go beyond the checklists and audits to ensure every
project is handled with precision, integrity, and innovation. By continuously improving our processes and
adopting cutting-edge technologies, we ensure that our clients not only comply with regulations but also
lead in delivering quality healthcare solutions.

Our mission is to provide the most reliable and preferred service platform to pharmaceutical companies
worldwide for research and development cycle, regulatory affairs and GMP compliance with higher
benchmark of quality, integrity and ethics.

Our mission is to enjoy the journey with best efforts towards achieving the end points with value driven approach.

We believe in core values of superior quality, transparency, ethical approach, confidentiality, zero conflict
of interest, accountability, honesty and constant improvement.

With our innate passion we are inspired to become the most trusted brand and reliable partner for pharmaceutical companies globally.

We inspire to become the synonym for quality, integrity, reliability in the mind of our clients when it comes to outsource their need in GCP, Regulatory Affairs and GMP.

We have set our vision with our passion to create an ecosystem where the teams of experts working towards get the best ground to bring out the best of their potential and divert it for the common end point of quality deliverables with in framed timelines.

We strongly believe in,

At Zenovel, Teamwork and Transparency is at the core of our work culture. We believe in the power of
collaboration, where every individual’s expertise is valued and shared toward achieving common goals.
Our teams work cohesively, leveraging diverse skills and experiences to overcome challenges and deliver
high-quality solutions.

We foster a supportive environment that encourages open communication, accountability, and mutual respect, ensuring that all team members contribute meaningfully. This collaborative spirit drives innovation and empowers us to consistently deliver excellence to our clients and partners.

With presence in almost 6 countries world-wide including India, Canada, Malaysia, China, USA, Australia we bring world together.

Reach out to us for any inquiries or support needs.

Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide

GCP

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

GCP

GMP

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

RA Services

AI-powered Regulatory Affairs Services

Pre Submission Service

Dossiers Related Services

Submission Services

Post Submission Services

Batch Release & Testing Services

Support & Staffing Services

RA Services

AI-powered Regulatory Affairs Services

Drug Dev. & Discovery

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

Key Expert Services

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

About Zenovel

Zenovel is a global leader in providing affordable, innovative, and high-quality solutions to the pharmaceutical industry. With over 20 years of expertise

With presence in almost 6 countries world-wide including India, Canada, Malaysia, China, USA, Australia we bring world together.

Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Ensuring Data Integrity: Best Practices and Considerations

Enhancing Clinical Studies with GCP Audit and Monitoring

Useful Links

Company

Contact Us