As companies expand their reach globally, numerous challenges — especially those pertaining to regulatory approvals — must be addressed.
In addition to providing contract manufacturing and lab testing services, Gaelic Laboratories, a manufacturer of beta-lactam products based in Clonmel, Ireland, markets its own generic antibiotic products in the UK, EU, the Middle East and North Africa (MENA).
Intending to launch them in new global regions, Ramprasad Kaparaboyena (RK), Regulatory Affairs Manager at Gaelic Laboratories (pictured), has recently managed the expansion of several product lines.
Here, he tells Dr Kevin Robinson (KSR) about the challenges that his team faced and offers guidance regarding how to overcome them.
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