Nitrosamine Impurity Risk Assessment

With a commitment to compliance and safety, our adept team navigates Regulatory complexities to ensure your product's integrity. Explore our specialized Nitrosamine impurity risk assessment services, meticulously tailored for the pharmaceutical and Biotechnology sectors.

Nitrosamine Impurity Risk Assessment - Overview

Nitrosamine impurities have gained significant attention from Regulatory authorities worldwide due to their potential health risks. Pharmaceutical companies must conduct thorough risk assessments to identify and mitigate the presence of nitrosamines in pharmaceuticals. Health Authorities such as the USFDA, EMA, MHRA, Health Canada, PMDA, and TGA have recognized the importance of addressing Nitrosamine impurities in drugs and have taken significant steps to mitigate nitrosamine risks and ensure the safety of pharmaceutical products.

Recently, the USFDA released a final guidance titled "Nitrosamines Drug Substance Related Impurities (NDSRIs)." This guidance addresses a subset of Nitrosamine impurities known as NDSRIs, which share structural similarities with Active Pharmaceutical Ingredients (APIs) in Medicinal products and often lack specific mutagenicity and carcinogenicity data for safety assessments.

The guidance focuses on predicting the mutagenic and carcinogenic potential of NDSRIs and sets recommended Acceptable Intake (AI) limits for them. It endorses the Carcinogenic Potency Categorization Approach (CPCA) to determine AI limits based on the structural features of NDSRIs. Additionally, it discusses alternative methods for justifying higher AIs, acknowledges the possibility of granting interim AIs to certain marketed products, and provides a new deadline for confirmatory testing and required changes in drug applications.

Make a note that the specifics of nitrosamine risk assessment can vary by country and Regulatory agency, and new research and data can lead to updates in risk assessments and regulations.

At Freyr, we specialize in Nitrosamine impurity risk assessment and offer a range of services to support pharmaceutical and Biotechnology manufacturers in this critical area. Our expert Regulatory team has in-depth knowledge and understanding of Regulatory guidelines, best practices, and the latest scientific advancements related to Nitrosamine impurities. We are committed to helping pharmaceutical and Biotechnology companies navigate the complexities of risk assessment, develop effective mitigation strategies, and ensure the safety and quality of your pharmaceutical products.

Nitrosamine Impurity Risk Assessment

  • Risk Assessments: Assessment to determine the potential risk of Nitrosamine impurities, which includes evaluation of all the risk factors related to the API synthesis process, the raw materials used, and the potential for cross-contamination.
  • Regulatory Compliance: Our experts stay up-to-date with the latest Regulatory requirements and guidelines, ensuring that your Nitrosamines risk assessment processes align with industry standards.
  • Remediation Strategies: Provide Strategies to address the regulatory compliance and update your registration Dossiers.
  • Experienced professionals with a deep understanding of Nitrosamine impurity risk assessment and Regulatory compliance.
  • Customized solutions that align with specific requirements and goals.
  • Timely assistance and support.
  • A proven track record of delivering high-quality services and solutions to pharmaceutical companies.

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​