Thought Leadership

Journal Article
The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include.
Journal Article
Efforts to build greater harmonization between global regulators are gathering momentum, partly due to changes brought about by COVID. This growing trend is likely to continue as regulatory authorities gain increasing confidence in collaborative initiatives that are still in their infancy.
Journal Article
The demands on life sciences companies are constantly intensifying. Resource constraints – whether workforce or the need to cut costs or streamline processes – different global regulatory requirements and the need to stay on top of technology advances create an increasingly complex environment for the industry.
Journal Article
Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to meet the needs of customers, in addition to an efficient and agile support system for resolution of unexpected situations.
Journal Article
Even though this is true in any business sector, it is particularly important for companies in the life sciences industry, where personnel must deal with many complex processes in a highly regulated environment to ensure both product and operations are compliant.
Journal Article
Efforts to improve the regulatory review process through standardization, harmonization, and digitalization have gathered steam in recent years with regulators and industry alike pushing forward with data-driven initiatives. Guest contributors from PharmaLex discuss what these mean for 2023 and beyond.
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