Wouldn’t it be nice to have a roadmap or a checklist to help you with the various areas of regulatory compliance?  Well, you’ve come to the right place.  Choose from the many tools below to help you with your compliance needs.

  • Checklist: FDA End-Use Letter Request for Drug Ingredients ($55)

Product Description: One of the most common reasons for why the FDA will request an End Use Letter is when a drug ingredient shipment is on hold and the FDA needs more information on the product in order to make the determination of whether or not to release it.  The most cost effective and timely way for you to get your product released is to provide the FDA with an End Use Letter which includes all of the information that the FDA is looking for.  This document will serve as a checklist to assist you in making sure that your letter includes all the necessary elements.

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  • Template: FDA End-Use Letter Request for Drug Ingredients ($65)

Product Description: One of the most common reasons for why the FDA will request an End Use Letter is when a drug ingredient shipment is on hold and the FDA needs more information on the product in order to make the determination of whether or not to release it.  The most cost effective and timely way for you to get your product released is to provide the FDA with an End Use Letter which includes all of the information that the FDA is looking for.  This document, one step up from a checklist, is a letter template which you simply have to fill in with your information, will serve as a tool to assist you in making sure that your letter includes all the necessary elements.

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  • Checklist: GHS Compliant Safety Data Sheet ($75)

Product Description: Whether you are writing, reviewing, or preparing information for a GHS compliant Safety Data Sheet (SDS) , it is ideal to have a checklist of the necessary elements handy.  This checklist is intended to be used as a supplement in addition to the user’s protocols, tools, and procedures, to assist in identifying SDS GHS compliance issues.

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  • Checklist: GHS Compliant Label ($45)

Product Description: Whether you are writing, reviewing, or preparing information for a GHS compliant label, it is ideal to have a checklist of the necessary elements handy.  This checklist is intended to be used as a supplement in addition to the user’s protocols, tools, and procedures, to assist in identifying label GHS compliance issues.

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  • 75 Acronyms Every Regulatory Professional Should Know ($15)

Product Description: If you are a regulatory professional working in the FDA regulated industry or the chemical industry, there are certain regulatory acronyms that you really should know.  But first one must narrow the list down from the thousands of acronyms out there to the ones more commonly used in these industries.  This document does that work for you.  So all you have to do is add the list to your knowledge base.

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  • Checklist: Nondisclosure Agreement ($75)

Product Description: A Nondisclosure Agreement, also known as an NDA, also known as a Confidentiality Agreement is a common type of Agreement circulating in the regulatory industry.  Whether you are getting ready to finalize an NDA or reviewing an NDA that was sent to you by the company you intend to work with, it is important to make sure that some of the most common provisions of the NDA have in fact been included in the Agreement.  This checklist will assist you in doing just that.

All sales are final.