Nitrosamine Impurity Risk Assessment & Mitigation Services for Pharmaceuticals

Our Nitrosamine Impurity Risk Assessment & Mitigation Services are designed to help pharmaceutical companies assess and minimize the risk of nitrosamine impurities in their products during the development phase. We ensure compliance with regulatory standards in major markets such as the USA, EU, Canada, and other global regulatory bodies, enhancing product safety and market readiness.

Key Deliverables

📌 Risk Assessment and Analysis – Comprehensive evaluation to identify and assess potential nitrosamine impurity risks in your pharmaceutical products.
📌 Regulatory Compliance Review – A thorough review to ensure compliance with USA FDA, EU EMA, Canada Health, and other relevant regulations.
📌 Mitigation Strategies & Recommendations – Tailored strategies and actionable recommendations to minimize nitrosamine contamination and enhance product quality.

Timeline & Milestones

Duration: 12 Weeks

🔹 Week 1-2: Initial Client Consultation & Data Collection – Detailed discussions with the client to understand product development and gather essential data.
🔹 Week 3-4: Nitrosamine Risk Assessment & Analysis – Conducting a detailed risk assessment to evaluate the presence of nitrosamine impurities.
🔹 Week 5-8: Regulatory Compliance Review & Strategy Development – Reviewing product compliance with global standards and developing mitigation strategies.
🔹 Week 9-12: Implementation of Mitigation Strategies & Final Report – Finalizing and implementing the strategies, followed by a comprehensive report.

Contact Us for Nitrosamine Risk Mitigation Services

For more information or to schedule a consultation, contact us at:
📧 phagloconsultancy@gmail.com | info@phaglo.com