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Case Study: Nitrosamine Impurities Analysis - Artixio’s Strategic Staffing Solutions for a Generic Drug Manufacturer based in the USA

Artixio stands out in the regulatory staffing industry by offering a unique blend of Lifesciences expertise, flexibility, and a global network of professionals. This case study outlines Artixio's experience helping with Nitrosamine Impurities Analysis through Strategic Staffing Solutions for a USA based Generic Drug Manufacturer.


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Client Overview

  • Client: A leading US-based generic drug manufacturer

  • Challenge: The client needed highly qualified and experienced professionals with expertise in Organic Chemistry, specifically for analytical roles to help with Nitrosamine Impurities analysis for their drug products.

  • Specific Skills Required:

  • HPLC-MS/MS analysis

  • Interpretation of MS data

  • Development and validation of analytical methods

  • Knowledge of regulatory requirements for ANDA/Dossier submissions


The Artixio Solution: Strategic Staffing for Nitrosamine Impurities Analysis

Understanding the Client’s Needs

  • Artixio’s team engaged in detailed discussions with the client to understand their staffing requirements.

  • The focus was on identifying professionals who had significant experience in Nitrosamine Impurities analysis and solid understanding of US FDA Guidance on Control of Nitrosamine Impurtities in Human Drugs (FDA-2020-D-1530).

Technical Evaluation and Candidate Selection

  1. Skill Assessment:

  • Artixio’s experts conducted rigorous technical evaluations to assess candidates’ proficiency in HPLC-MS/MS analysis, MS data interpretation, and method development/validation and specific experience in Nitrosamine Impurities Analysis.

  • Only candidates with proven expertise were shortlisted.

  1. Regulatory Knowledge:

  • Artixio ensured that candidates possessed a solid understanding of regulatory requirements for analytical documentation in the context of ANDA/Dossier submissions.

  • This was critical for compliance and successful product approvals.

  1. Right-First-Time Approach:

  • Artixio presented a carefully curated pool of candidates to the client.

  • The client appreciated the quality and precision of the selection process, leading to swift approvals.

Seamless Onboarding and Fulfillment

  1. Client Approval:

  • The client approved the selected candidates promptly, thanks to Artixio’s thorough evaluation process.

  • The right-first-time approach minimized delays and streamlined the staffing process.

  1. Resource Deployment:

  • Artixio facilitated the seamless onboarding of the chosen professionals.

  • The candidates were ready to contribute from day one, minimizing any learning curve.

  1. Budget-Friendly Solution:

  • Artixio’s efficient staffing approach ensured that the client’s needs were met within the allocated budget.

  • Cost-effectiveness was a priority without compromising on quality.

Results and Impact

  • Artixio successfully fulfilled the client’s staffing needs within a short time frame.

  • The selected professionals seamlessly integrated into the client’s team, contributing to ongoing projects.

  • The client appreciated Artixio’s industry expertise, technical acumen, and commitment to delivering value.

Conclusion

Artixio’s strategic staffing solutions go beyond matching resumes. By understanding client requirements, conducting rigorous evaluations, and ensuring regulatory alignment, Artixio delivers staffing excellence that drives organizational success.

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