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Batch Release & Batch Testing Site Support Services

Ensure pharmaceutical excellence by one batch at a time

Batch Release and Batch Testing Site Support Services

We extend batch release and testing site support services to ensure your products meet high quality and compliance standards. We understand the importance of precise and timely batch release and testing, and are dedicated to supporting your success.

  • Overview

We provide GMP-certified importation, batch testing, and batch release services for human, veterinary, and investigational medicinal products. With multiple QPs and MIA holders, we can perform GMP batch testing and release for sterile, non-sterile, and biological medicinal products. Most of our clients are global manufacturers without mutual recognition agreements (MRA) importing their products within the developed countries. Batch testing is mandatory before batch release, and Zenovel’s integrated solution includes batch release for these manufacturers, allowing them to entrust their products until market release.

  • Method  Development, Validation, Transfer
  • Two EU facilities are dedicated to developing and validating analytical methods for the CMC of small molecules or biologics, which are EMA, FDA, and GMP approved.
  • We use thorough procedures to transfer, validate, or create pre-qualified techniques.
  • Our skilled staff, exposed to various APIs, excipients, preservatives, intermediates, & completed pharmaceutical products; often serve as the starting point for initiatives in various fields.
  • Fields such as- recognition, assay evaluation, biological efficacy, dissolution tests, remnants solvents, elemental contaminants,  nitrosamine and genotoxic impurity, distribution of particles size, techniques of demonstrating stability, other tests with certain CMC departments, cleaning & process validation,  Orally & Nasally Inhaled Drug Products (OINDPs).
  • We use GMP certified validated instrumentation for the development of analytical procedures.
  • Zenovel provides GMP-certified ICH stability studies for global pharma clients, analyzing various products like tablets, capsules, ampoules, topical products, injectables, & powders.
  • With walk-in climatic chambers & fully equipped laboratories, we use comprehensive method validation designs according to ICH guidelines, US and EU recommendations, & clients’ requirements.
  • We have extensive experience in stability testing services.
  • The test involves such as long-term, intermediate, & accelerated stability, ongoing studies, preliminary stability studies for API and FDF, development & validation of stability indicating methods, stress testing, ICH phot stability testing, leachable determination from packaging, in-use stability studies, GMP stability storage, holding time studies, temperature cycle tests, freeze-thaw, and transportation management.
  • Our CMC tests for biological pharmaceuticals are designed for various customers including biotech companies, global biosimilar manufacturers, bioprocessing facilities, API producers, and fill & finish factories.
  • We use an integrated orthogonal strategy and multiple methodologies to thoroughly understand the analytical fingerprint of complex compounds.
  • We conduct routine quality control of biologics drugs, characterization of new biologics, comparability studies.
  • Quality Control of biologics and biosimilar
  • Our CMC tests for biological pharmaceuticals are designed for various customers, including biotech companies, global biosimilar manufacturers, bioprocessing facilities, API producers, and fill & finish factories.
  • We use an integrated orthogonal strategy and multiple methodologies to thoroughly understand the analytical fingerprint of complex compounds.
  • We conduct routine quality control of biologics drugs, characterization of new biologics, comparability studies.
  • Identify root cause and implement corrective action to maintain quality and compliance in batch testing site support.
  • We review necessary documents – Certificate of analysis, batch records, quality control reports for confirmation of compliance and accuracy.
  • Why Choose Zenovel ?
  • Expertise and Experience

Our team of professionals brings extensive experience in pharmaceutical quality control and regulatory affairs.

  • Modern Facilities

We advanced testing and release services are powered by state-of-the-art laboratories and advanced technologies.

  • Customer Oriented Approach

We work thoroughly with our clients to fully grasp their individual demands and then customise our offerings to fulfil those needs.

  • Compliance and Integrity

Our commitment to strict regulatory standards and integrity ensures the safety and effectiveness of our products in all our operations.

Blogs and news

Our Latest Article

Nitrosamine Control

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.

Read More
Nitrosamine Control

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

Read More
Risk-Based Monitoring

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

Read More
Mastering Inhalation Studies

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

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Data integrity

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

Read More
GCP Audit and Monitoring

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

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

  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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