Life Sciences Compliance
Patricia Santos-Serrão
RAC Regulatory Advisor
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DIA EDM Reference Model
Posted: 269 days ago
By now most of the individuals reading this blog are familiar with the DIA EDM…
Read MoreFDA Opens First Overseas Office in China
Posted: 610 days ago
We’ve all read and heard about the numerous headlines regarding contaminated products produced in China…
Read MoreWhat are the concerns about BPA?
Posted: 622 days ago
As an expectant mother (for the first time) I have been reading many books and…
Read MoreDiscussion: What have been your eCTD Challenges?
Posted: 636 days ago
As the end of 2008 approaches with about 9 weeks left in the year I…
Read MoreFDA Issues Draft Guidance for Comment on Development Safety Update Report
Posted: 709 days ago
On August 4, 2008 the FDA issues draft guidance on the purpose, content and format…
Read MoreShould Food Dyes be Banned?
Posted: 783 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: 927 days ago
The New Year is now upon us, and with the New Year comes a number…
Read MoreRisk Management: Importance of Labeling
Posted: 933 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: 974 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: 1099 days ago
If you are like me, you’ve been hearing about eCTD for years. While some have…
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Warren Perry
Senior Compliance Advisor
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Protecting your Intellectual Property - From a Biotech point of view.
Posted: 723 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: 868 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: 974 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: 707 days ago
Firstly, for those of you who are not familiar with this particular DocCompliance setting, let…
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