Life Sciences Compliance
Patricia Santos-Serrão
RAC Regulatory Advisor
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FDA Issues Draft Guidance for Comment on Development Safety Update Report
Posted: 17 days ago
On August 4, 2008 the FDA issues draft guidance on the purpose, content and format…
Read MoreShould Food Dyes be Banned?
Posted: 91 days ago
We are all familiar with the various colors that we associate with foods; strawberries are…
Read More2008 - The Year of the eCTD
Posted: 235 days ago
The New Year is now upon us, and with the New Year comes a number…
Read MoreRisk Management: Importance of Labeling
Posted: 241 days ago
In 2007, the importance of drug labeling in the safety of patients has received national…
Read MorePresentation: The Importance of Document Management When Designing a GRSD
Posted: 282 days ago
You are invited to join me at the upcoming RAPS Regulatory Strategy Forum in Atlanta,…
Read MoreLooming eCTD deadline....are you ready?
Posted: 407 days ago
If you are like me, you’ve been hearing about eCTD for years. While some have…
Read MoreNew Year's Resolution
Posted: 610 days ago
For centuries, we’ve been using the arrival of a new year as an excuse to…
Read MoreChanges in Washington: Will it affect the Pharmaceutical Industry?
Posted: 626 days ago
Healthcare has always been stated as a priority with both political parties during an election…
Read MoreFDA Invites Input on Electronic Submission of Regulatory Information: Public Hearing to Focus on Transforming to an All-Electronic Environment
Posted: 644 days ago
The Food and Drug Administration (FDA) announced on November 16, 2006 a plan to hold…
Read MoreSound Document Management Lays the Groundwork for Successful Regulatory Publishing
Posted: 655 days ago
A good Electronic Document Management (EDM) system is the foundation of a solid, complete document…
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Warren Perry
Senior Compliance Advisor
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Protecting your Intellectual Property - From a Biotech point of view.
Posted: 31 days ago
The ‘holy grail’ for many start-up biotech companies is to bring a product to clinical…
Read MoreHow is the FDA Progressing with its Risk-based Approach to Compliance?
Posted: 176 days ago
The video blog features QUMAS Compliance Advisor, Warren Perry, who has worked with a number…
Read MorePresentation: Sound policies and procedures form the foundation for successful compliance programs
Posted: 282 days ago
Just a quick update on my speaking schedule: I will be speaking at SourceMedia’s Tech…
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Geraldine Foley
Project Manager
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Review Copies: Keep or Not to Keep? That is the Question....
Posted: 15 days ago
Firstly, for those of you who are not familiar with this particular DocCompliance setting, let…
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