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Clinical Research Solutions
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...
Clinical Research Solutions
Blood Plasma, or simply plasma, is the liquid portion of blood. It has a number of vital functions in bleeding and infection control. It contains proteins and antibodies, which are produced by the...
Clinical Research Solutions
Regulations require the pharmaceutical industry to be compliant, have and maintain a quality system, and build quality into the process (quality by design). What does that truly mean and how does the...
Clinical Research Solutions
Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a...
Clinical Research Solutions
Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...
Clinical Research Solutions
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
Clinical Research Solutions
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...
Clinical Research Solutions
The Prescription Drug User Fee Act (PDUFA) is due to be reauthorized by the end of September this year. Along with the usual increases in fees, the latest version of the act (PDUFA V) includes some...
Clinical Research Solutions
In a recent FDA Drug Safety Communication, the Agency announced that the Celexa (citalopram hydrobromide) label now has revised dosing recommendations based on evaluations of post-marketing reports...