Investigation and Control of Nitrosamine with International Scientific Support

In the complex and regulated landscape of pharmaceutical manufacturing, ensuring the safety and compliance of your products is paramount. Nitrosamines, known for their carcinogenic potential, pose a significant challenge during drug development and manufacturing. 

Our service offers comprehensive support from experienced investigators to guide and assist you in dealing with nitrosamine impurities from formulation development through to commercial batch production and regulatory submission.

Veeprho’s Support Services

Comprehensive Nitrosamine Management Across All Stages:

  • During Synthesis of API and Formulation Development: Our investigators work closely with your team to identify potential sources of nitrosamine contamination, implementing strategies to mitigate these risks from the earliest stages of drug development.
  • At the Time of Pilot Batch: As you scale up from laboratory to pilot scale, our experts guide you in adapting your nitrosamine control strategies to larger volumes and more complex manufacturing processes, ensuring consistency and safety.
  • At the Stage of Bio-Batch: Prior to clinical trials, our service includes a thorough review and adjustment of nitrosamine risk management practices to safeguard patient safety and meet regulatory expectations for bioavailability and bioequivalence studies.
  • After Completion of Dossier Before Submitting to FDA: Before you submit your regulatory dossier to the FDA or other regulatory bodies, our investigators provide a final review and support to ensure that all aspects of nitrosamine control are adequately documented and in full compliance with regulatory guidelines.

Why Choose Our Service?

  • Expert Guidance: Benefit from the expertise of seasoned investigators who understand the intricacies of nitrosamine risk assessment and control throughout the pharmaceutical development and manufacturing process.
  • Regulatory Compliance: Stay ahead of regulatory requirements with a service that is fully aligned with FDA, EMA, and other relevant guidelines for nitrosamine testing and control.
  • Risk Mitigation: Proactively address potential nitrosamine impurities, minimizing the risk of costly recalls and protecting patient health.
  • End-to-End Support: From early development stages through to commercial production and regulatory submission, our comprehensive service ensures you have the expert support you need at every step.

Our Approach

Our investigators employ a systematic approach to nitrosamine control, combining state-of-the-art analytical techniques with deep regulatory expertise. We work collaboratively with your team, offering tailored support that fits your specific needs and challenges.

Frequently Asked Questions

What makes your service unique?

Our service is distinguished by its comprehensive coverage, expert team, and commitment to staying at the forefront of regulatory and scientific developments in nitrosamine control.

How quickly can we implement changes based on your recommendations?

Our goal is to provide actionable recommendations that can be implemented swiftly to mitigate risks effectively, with timelines varying based on the complexity of the required changes.

Count on Veeprho For Scientific Support On Investigation and Control of Nitrosamines

To learn more about how our Scientific Support for Nitrosamine Investigation and Control can protect your products and patients, contact us today. Our team is ready to provide the expertise and support you need to navigate the challenges of nitrosamine control with confidence.

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