An arduous endeavour?
Indian pharma companies are pushing for 'third country' status from the EU regulatory authorities for India's Schedule M and GMP…
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cGMP implementation: From philosophy to practice
Advocating a quality systems approach for cGMP implementation, SM Mudda, Executive Director-Technical & Operations, Micro…
US FDA cGMP regulatory compliance by Indian pharma: An impossible dream?
Ram Balani, CEO-Founder, FDASmart Inc, sheds some light on the compendium of errors committed by Indian pharma manufacturers and…
Surviving a regulatory audit
In the regulatory compliance domain, one of the common failures cited by the regulatory authorities in their warning letters is…
Creating a culture of quality and compliance
Dr Kavita Mehrotra, Head, Global Strategic Alliances, UL (Underwriters Lab), Scott Barnard, VP & Practice Leader, Advisory…
Optima to exhibit at Interpack
Focus will be on flexibility, high outputs and line solutions offering users best possible RoI
Merck Serono appoints Meeta Gulyani as Head of Strategy and Global Franchises
Joins Merck Serono from Roche
US FDA approves Myalept to treat rare metabolic disease
The safety and effectiveness of Myalept, an analogue of leptin made through recombinant DNA technology, were evaluated in an…
Jubilant Life Sciences resolution for Montreal facility
Jubilant Life Sciences has received a communication from the US Food and Drug Administration (US FDA), classifying its…