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With the right blend of experience, skill, innovation, and in-depth expertise in pharmaceutical regulatory affairs, we are dedicated to providing top quality regulatory services to our clients.
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Generic Drug User Fee Amendments
The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed.
On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User Fee Amendments (GDUFA).
New Product Authorizations
Impact of Brexit on the Pharmaceutical Industry
Following the exit of the UK, a transition period began on February 1, 2020, during which European Union (EU) pharmaceutical law remains applicable to the UK. But this is due to end on December 31, 2020. This means that pharmaceutical companies can carry out their activities in the UK until the end of 2020.
Nitrosamine Impurities: A Regulatory Perspective
In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine impurity had been detected in a pharmaceutical drug.
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