Thought Leadership

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.
Journal Article
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
Journal Article
The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again cosponsored the 2022 PDA/FDA Joint Regulatory Conference with the theme, “Quality Evolution/Technology Revolution: Modern Quality Management Solutions.” Due to the COVID-19 pandemic, there became a pressing need to address the public health crisis, which led to some introspective thinking among industry and regulators about improving communication and embracing innovation and technology. This emphasis on improvement was the overarching message from the PDA/FDA conference.

Mark Lane | PharmaLex Expert

Get to Know Mark A. Lane, PhD, VP of Development & Scientific Affairs
Journal Article
Like the previous workshops, this event was characterized by a mix of presentations on specific Annex 1 topics combined with interactive workshops, whereby participants had the opportunity to ask the panel of experts about the presented subjects. Above all, it provided the opportunity to discuss the participant’s interpretation, challenges and possible solutions with peers from the industry. Based on the number of questions asked of the panel, this turned out to be a very successful workshop with a high level of interaction between participants and presenters and during round-table discussions.
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