Search results for " pharmaceutical"
Resource
The Pharmaceutical Manufacturers Association
Its name was changed to the Pharmaceutical Research and Manufacturers of America in 1994. Headquartered in Washington, DC, PhRMA represents the country’s leading pharmaceutical research and biotechnol…
Resource
International Society for Pharmaceutical Engineering
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and th…
Article
Regulatory Challenges in the QbD Paradigm
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry and regulatory authorities across the globe. These changes are necessitated by a pl…
Article
Understanding Validation and Technical Transfer, Part I
Large-molecule drug products and attendant manufacturing processes often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule pharmaceutica…
Article
Drug Discovery and Development in India
Over the past few years, Indian pharmaceutical companies have been attempting to re-orientate their efforts toward developing new innovative medicines, Ang Wei Zheng, analyst of Business Monitor Inter…
Article
Contract Manufacturing Through the Years
…ufacture; Vetter offered bulk syringe filling; DPT had semisolid and liquid capabilities; and Custom Pharmaceuticals, the forerunner of Patheon, manufactured primarily over-the-counter (OTC) products…
Article
Climate Change in Outsourcing
Government budget cuts also threaten support for pharmaceutical research, especially the work of the National Institutes of Health in the US.
On the positive side, central bank efforts to hold dow…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…
Article
Biotechnology Innovation and Growth in Israel
Its dense population and focus on innovation positions Israel well to drive a significant amount of growth for pharmaceutical and medical-device manufacturers.
The infrastructure of…
Article
Supplier-Change Management for Drug-Product Manufacturers
This article provides an overview of the pharmaceutical SIC process, including a discussion on the need for control of SICs, a review of change notification scope and content, and a summary of how SIC…