Competencies

Global Leading Solutions with Unmatched Competency for Pharmaceutical Success.

Our core competencies are based on quality, compliance, integrity, and understanding of the industry’s needs, making us the preferred partner for pharmaceutical companies seeking success in clinical and regulatory endeavours.

1) GCP Services

We offer an all-inclusive range of clinical trial services, from Phase I to Phase IV, including patient-based bioequivalence (BE) and pharmacokinetic (PK) studies, as well as therapeutic-based research tailored to meet specific client needs.

With over 17 years of industry experience across various therapeutic areas.

With more than 1500 GCP monitoring, around 200-300 BA/BE studies audit, 150 Phase I, 20 Phase II, 45 Phase III, and 18 Phase IV studies, along with medical device trials

Ensuring compliance with global regulations with team members across key global regions like India, USA, Canada, EU; more than 25 countries across the Globe.

Experts in patient-based bioequivalence (BE) studies, first-in-human trials, and complex phases of clinical trials (Phase I-IV).

Skilled teams in Clinical Development, Regulatory Affairs, GMP Auditing, and adept as per requirements.

We ensure that your facility and staff are fully prepared to pass FDA inspections, providing the necessary support for inspection readiness.

2) GMP Compliance Services

We utilize our expertise in pharmaceutical production plant design, regional building resources, architectural restrictions, and regulatory requirements to assembly GMP compliant pharmaceutical and biotech projects.

Audits performed at manufacturing sites in India, China, Vietnam, S. Korea, Taiwan, Malaysia, Turkey, USA, Europe, UK, and many others

Having conducted numerous audits, Zenovel now has a GMP Audit Report Library with Long Validity of GMP Audit Reports

Team of experts with 20+ years of experience in the GMP Domain

Strong In-house SOPs and Training Systems to perform the audits First of few companies to introduce concept of GMP monitoring

3) Regulatory Affairs

Our team excels in navigating the complex regulatory landscape, offering comprehensive services that ensure timely regulatory submissions with all necessary compliance documents. We guarantee that your products meet stringent global guidelines and regulations.

Team of experts with 15+ years of experience in designing and implementing Regulatory Strategies in compliance with global regulatory standards.

All-round competencies in Regulatory Affairs domain including all fine aspects covering – Dossiers, Site transfers and Post approvals.

All-round competencies the in quality assurance domain including all fine aspects covering – Process Validations, Documentation, In-Process quality assurance, Deviations and Change controls.

More than 125+ MAA Submission experience (Dossier).

More than 300+ post approval Submission experience to various regulatory agencies.

Experience for the review of manufacturing documents like batch manufacturing record, process validation protocol and report, batch packing record and stability protocol.

Involved in anticipating regulatory issues in drug development and work to eliminate/minimize regulatory issues.

Hands-on experience of eCTD software for EU and US.

Expertise in clinical and nonclinical writing

Expertise in admin documentation (especially Module 1).

Hands-On experience in Dossier review for Regulated and semi-regulated market.

Expert in dossier extension. Especially for gap assessment of one market to another.

Documentation and review of data of executed development, feasibility and scale-up batches.

4) Key Expert Services

Cover IT solutions, preclinical support, CMC development, and intellectual property protection, offering a comprehensive one-stop solution for all your 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

Competencies

Global Leading Solutions with Unmatched Competency for Pharmaceutical Success.

1) GCP Services

2) GMP Compliance Services

3) Regulatory Affairs

4) Key Expert Services

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

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