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…
Biomarker discovery presents opportunities for players in Parkinson’s Disease market:…
GlobalData predicts PD prevalence to increase from 2.5 million patients to 3.2 million across the seven major markets
Lupin receives approval for acne treatment
Lupin has received final approval for its Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drugs…
Claris Lifesciences posts consolidated revenues at Rs 7,084 million
EBITDA margin reported at Rs 2,100 million
Strand receives US patent for virtual liver model
Announces release of the human version of the virtual liver model
GSK increases stake in local pharma subsidiary to 75 per cent after open offer
GlaxoSmithKline accepts 20,609,774 shares of GlaxoSmithKline Pharmaceuticals
Focus on speciality pharma drives M&A activity in Feb 2014
Indian pharma sector witnesses no deals during February 2014
IPC-IMA TNSB Pharmacovigilance CME held at Chennai
Saw participation of 75 clinicians and pharmacologists
IPA-MSB, IPA-CPD organises training programme for pharmacists
The programme had a mix of lectures, interaction, demonstrations and panel discussions
Industry introspects at Healthcare & Pharma Expansion Summit 2014
Regulatory reform, need for practical roll out of new guidelines were key concerns
Bitter medicine
Name-Shame-Blame-Train. This has been the pharmaceutical industry's mantra to manage non-compliance