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ComplianceNet, Inc. -- Biotech and Pharma Quality and Validation Consulting Services

 
 
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Quality and Consulting Services
for Biopharmaceutical and Pharmaceutical Companies

ComplianceNet, Inc. provides a wide variety of services to help companies meet international regulatory challenges. Consultants specialize in guiding small, start-up firms to establish efficient, cost effective and quality systems, which will pass inspection and produce high quality products.  Recommendations related to Regulatory Compliance strive to match the level of each client firm's stage in the Drug Development Process - Pre-Clinical, Phase I through Phase III, up to and including Market Product.

ComplianceNet consultants have varied expertise in all aspects of Quality, from writing SOPs, protocols and Master Plans needed to set up a new manufacturing facility to reviewing existing systems for compliance, effectiveness and efficiency.  The pool of experts includes specialists in auditing (including extensive international experience with a practical knowledge of specific European regulatory requirements), process validation, computer validation (including 21 CFR Part 11 compliance), equipment qualification, utility and environmental monitoring, microbiology issues, and all aspects of manufacturing.  

Also offered are on-site GMP training seminars in a wide variety of topics, such as API GMP Compliance, Process Validation Compliance for Biopharmaceuticals, and Electronic Records and Signatures Compliance.  Courses can be presented on-site so that many personnel can benefit from the knowledge, for the cost of sending one or two people to an off-site event.  

All ComplianceNet consultants come from biopharmaceutical backgrounds and have worked successfully with many traditional pharmaceutical and gene therapy clients.  A recent area of emphasis has been worldwide vaccine production.

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If you have a quality system that needs implementation but are short on staff or experience, we can help you start it or fully implement it.

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If you are concerned about compliance at your contract manufacturer, laboratory, or raw material supplier, we can help you assess them.  

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If you think now is too early to think about Process Validation, think again.  The more thought you put into defining your product and process early on, the more money and time you will save in getting to market.  Start now.  We can show you the critical things to consider to make this complex project much easier.

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If your existing quality system is too cumbersome and labor intensive, we can provide alternative systems or reengineer the system.

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If you have validation or qualification projects that need to be completed ASAP, we can jump in and get it done.

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We have experience with dozens of Environmental Monitoring programs and Utility Monitoring programs.  Let us show you what works and why.  Don't let these critical programs be paper producing exercises.  Turn them into systems that will improve the quality of your product and reduce later expenses for Investigations and product rejects.

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We can help you significantly reduce the time and manpower required to complete your projects.  Contact us today to discuss your needs.


Did you know?

"Contrary to popular belief, FDA people do go to heaven, and when I get to heaven I'm going to ask God if he's been following Q7 [the API GMPs]."

Edwin Rivera Martinez
CDER, FDA

 

Copyright 2003 Compliance Net, Inc.

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