article thumbnail

FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

With extensive experience in manufacturing techniques and regulations, the CMC services team at Premier Consulting can help sponsors navigate the development of advanced manufacturing technologies. Examples of technologies which have been accepted as an ETP include 3D printing manufacturing and continuous manufacturing processes.

FDA 52
article thumbnail

CDMO Selection: The Ultimate Checklist

Drug Patent Watch

Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place. This peer-to-peer perspective offers invaluable information, empowering pharmaceutical companies to make an informed decision. 2019, March 6). Contract Pharma.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD). That requires taking every possible step to characterise dosage and physiological responses.

article thumbnail

How AI will reshape pharma by 2025

Drug Target Review

However, he believes that these fears will dissipate as pharma companies come to realise that AI firms like Unlearn adhere to stringent data control measures, ensuring the ethical use of patient information. Regulators care a lot about controlling the Type 1 error rate of the clinical trial, Smith notes.

article thumbnail

Streamlining the Generic Drug Supply Chain: Best Practices

Drug Patent Watch

By implementing these strategies, manufacturers, distributors, and regulators can work together to improve efficiency, reduce costs, and increase patient access to affordable medicines. Data-Driven Decision Making : Leverage data analytics to inform decision-making, identify areas for improvement, and optimize the supply chain.

Drugs 77
article thumbnail

Universal Design for Visual Disabilities in Healthcare – Braille and Large Print – 11

Perficient: Drug Development

Universal design (UD) in healthcare ensures that facilities, services, and information are accessible to everyone, regardless of their physical abilities. This approach encompasses architectural designs, patient communication methods, and even the format of health information.

article thumbnail

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

Improved Security and Intellectual Property Protection : Integrated CDMOs can more easily control which employees have access to information, enhancing the security of intellectual property.