News and Resources

Integrated clinical development and supply: Breaking down the early-development journey of a small molecule.

Check out this replay of a Catalent-sponsored webinar where Mark Krook, Head of Early Drug Development at NGT BioPharma Consultants, presented his thoughts and insights on an integrated drug development approach for small molecules! 

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NGT BioPharma Consultants Welcomes Roger Nosal, Head of Regulatory Strategy

NGT BioPharma Consultants Welcomes Roger Nosal. Prior to September 2022 he was Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer where he was accountable for development, preparation & prosecution of global regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines including the COVID-19 mRNA vaccines and gene/cell therapies).

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“Integrated Clinical Development and Supply: Breaking Down the Early-Development Journey of a Small Molecule”

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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Don’t Forget About Quality When Formulating Your Drug Development Plan

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.

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

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

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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