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Regulatory affairs


Addressing regulatory matters in a timely and accurate manner is an important factor for the success of our customers.

This is achieved through:

•  a thorough understanding of expectations, requirements and regulatory filing
   procedures in relation to EU, USA, China, Japan, Taiwan Korea, Brazil, India, Russia, Ukraina registration dossiers

•  a detailed knowledge related to the management of variations and changes in
   accordance with local regulations

•  continuously updating our regulatory personnel on the latest practices and
   policies of the appropriate authorities (MHRA, TGA, FDA, AIFA, EMA,…)

Drug Master Files

To view the status of our Drug Master Files, click on the name of a product from our list: