Thought Leadership


Regulatory Affairs & CMC Services at PharmaLex

Journal Article
Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
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.
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