Documentation Drug Development Pharmaceutical Companies 
Drug Patent Watch
DECEMBER 10, 2024
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.
STAT
JANUARY 19, 2023
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.
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European Pharmaceutical Review
SEPTEMBER 22, 2022
Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance.
Drug Patent Watch
DECEMBER 9, 2024
Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.
Express Pharma
MARCH 16, 2025
In India, pharmaceutical companies responded to global environmental concerns and government mandates by adopting greener manufacturing techniques. First, advanced research and development (R&D) and biologics will be critical. This transition will require substantial investments in several key areas.
Pharmaceutical Technology
JUNE 15, 2023
The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.
European Pharmaceutical Review
SEPTEMBER 2, 2022
The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.
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