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How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

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Responsible sourcing and manufacturing: Growing towards a sustainable future with Lonza

Express Pharma

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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FOPE and PharmaState Academy complete second PULSE session on pharmaceutical quality systems

Express Pharma

The session focused on the critical topic of Pharmaceutical Quality Systems, lasted over three hours, and included extensive discussions and a Q&A session. The event was attended by over 900 participants with more than 2000 views on various social media platforms.

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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog: Biosimilars

HP&M is proud to have our professionals participating in these important events. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. We can offer our readers a special discount for the event.

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Pharma Analytics Quiz

PharmaState Academy

Name Email Phone Number Company Department State City 1 / 15 How does analytics support adherence to regulatory guidelines in the Indian pharmaceutical manufacturing sector? 2 / 15 In the Indian pharmaceutical industry, what does analytics-driven supply chain management primarily focus on?

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The cluster effect: Connectivity and collaboration in life sciences hubs

Pharmaceutical Technology

From the Human Genome Project to contemporary drug development, collaboration is critical to the life sciences. It is also an important factor in the success of life sciences clusters, where a high concentration of pharmaceutical or medical device companies can all be found in one district, city or region.

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NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development.