Nitrosamine Program Management

Treximo is a global outsourcing and consulting partner to industry-leading Biotech, Pharmaceutical, and Medical Device companies. Quality is at the heart of everything we do. We ensure risk assessment and manufacturing improvement at every turn.

Nitrosamine Impurities

In April 2020, the FDA requested all ranitidine products be withdrawn from the US market after preliminary results from stability testing raised concerns that levels of N-Nitrosodimethylamine (NDMA) in some products stored at room temperature could increase with time to unacceptable levels.

Further testing showed nitrosamine impurities in other drug products such as angiotensin II receptor blockers (ARBs), nizatidine, and metformin. This revelation has created an urgent need for risk assessment, remediation, and new regulatory submissions for all nitrosamine-containing drugs.

Manufacturers are responsible for understanding their processes, which includes preventing the presence of unacceptable impurities. Pharma companies are also responsible for developing and using suitable methods to detect and limit unacceptable impurities, including those that may arise when making changes to the manufacturing processes.

Assessment,
Compliance, and Improvement

What is the best course of action to assess your risk? Some manufacturers have already had their drugs recalled while others have done so on their own as a precaution.

How will you comply with evolving FDA regulations? As more nitrosamine data is revealed, agencies worldwide will set their own regulations to which you must comply.

Once your plan is outlined, how will you improve manufacturing capabilities, not only for compliance, but to ensure an expeditious return to market?

How Treximo Can Help

Global Regulatory Strategy

Risk Evaluation and Mitigation Strategies (REMS)

FDA Advisory Committee Support

Regulatory Operations

PMP-certified Experts to Manage Submissions and Ensure Efficiency

Risk-based Quality Management

Medical Writing

Medical Monitoring

Pharmacovigilance

Work With Us to Assess Your Nitrosamine Risk, Comply with FDA Regulations and Improve Your Manufacturing Processes

Compliance

In such a highly regulated industry, compliance is an essential factor to consider. We bring up-to-date knowledge and expertise to ensure our clients are fully covered in every scenario. Our team acts as a resource to reliably guide our clients to optimal compliance.

Risk Management

Our services help our clients meet product safety issues in an assured, proactive way. We back up clients daily with the progress of clinical and post-approval tactics. Our consulting and preparation services make up the expansion of essential safety specifications and risk minimization tactics.

Industry Expertise

According to the Cambridge English Dictionary, expertise is defined as ‘a high level of knowledge or skill.’ When it comes to FDA regulations and compliance, our team has an extraordinary amount of industry knowledge and skillfulness at delivering results for our clients.

Clinical Individual Case Safety Reports

We create regulatory-friendly reports for clinical and marketed products to ensure compliance. Our team delivers client-approved operation procedures such as submission-prepared paperwork.