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In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me ...
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance ...
There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference ...
One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to ...
The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is ...
A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over ...
GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during ...
Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine ...
For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity. It is an open ...
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, ...
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, ...
Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure ...
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