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  • Home
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    • Discovery & Investigative Research
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    • Regulatory Strategy & Dossier Preparation
    • Quality & Compliance
    • Advanced Technologies
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Don’t Forget About Quality When Formulating Your Drug Development Plan

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It is not uncommon for small biotech and biopharma startup companies to overlook Quality & Compliance when formulating their drug development plans and budgets. However, industry guidance from the International Conference on Harmonization (ICH) recommends that serious consideration be given to Quality Assurance (QA) very early in the process.

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Digital Validation – Why BioPharma is Going Paperless.

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The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.

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CMC Expertise: Paving the Road for Product Development

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The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.

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NGT BioPharma Consultants Welcomes Daniel Schaufelberger, VP Chemistry, Manufacturing, & Control (CMC)

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NGT BioPharma Consultants Welcomes Daniel Schaufelberger, VP CMC and Specialist in Pediatric Drug Development.

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NGT BioPharma Consultants Welcomes Michelle McGuinness, VP Regulatory Strategy & Submissions

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NGT BioPharma Consultants Welcomes Michelle McGuinness, VP Regulatory Strategy & Submissions

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Listen to NGT’s Alton Johnson speak on this episode of Voices in Validation’s “Digitization Of Validation For Effective Virtual Regulatory Inspections.”

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As we continue to face business impacts of COVID, a new normal may be emerging in regulated industries, such as pharma and medical devices, when it comes to site visits and audits. As agencies like the FDA continue to rely on the virtual inspection, we need to take a look at the process, including review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes? In this episode we bring a panel disucssion to help us better understand the intricacies of remote inspection featuring Dr. Ajaz Hussain, Dr. Alton Johnson, and Steve Thompson.

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