The CMC Regulatory Process and Documentation Writers: We’ve Got Chemistry

CMC Regulatory Process
CMC Regulatory Process

Before a pharmaceutical drug is put on the market for the general public it must undergo a lengthy regulatory process. This ensures both the safety of the drug, as well as the safety of its manufacturing process. This regulatory process is more commonly known as CMC, or Chemistry, Manufacturing, and Controls.

Chemistry, Manufacturing, and Controls: At a Glance

The CMC process is an umbrella term which describes the regulatory process pharmaceutical drugs go through in order to become approved by the US Food and Drug Administration. This process is put in place in order to ensure that pharmaceutical drugs are not only effective, but also safe for the consumer.

The CMC process applies not only to the drug itself, but also the manufacturing company by which it is produced. The process is applicable to the entire product life cycle, starting in the drug candidate selection phase.

The process includes thorough evaluation of the following:

  • Manufacturing process
  • Quality control evaluation
  • Specification and stability of product
  • Design and operation of manufacturing facility 
  • Maintenance and functionality of the manufacturing facility

Documentation Writers and the CMC Regulatory Process

It will come as no surprise that a great deal of paperwork and documentation is involved in the lengthy CMC process. Here is where the need for technical and documentation writers comes in.

In order for pharmaceutical companies to pass the CMC process with flying colors, a documentation writer is absolutely necessary to ensure the verification and legality of the regulatory process via paperwork and technical documentation.

The regulatory process is a lengthy trial for which a copious amount of documentation and paperwork is necessary, including written analytical methods and verification procedures relating to drug manufacturing. Hiring a documentation writer can ensure that this documentation is done quickly, accurately, and comprehensively, saving your company time, money, and headaches now and in the future!

To Master CMC, Hire With EDC!

 A writer provided by Essential Data Corporation works closely with the contract manufacturing organization whilst abiding by internal regulatory systems to efficiently write these documents in compliance with industry guidelines.

From the early to late stage of product development, a documentation writer from Essential Data Corporation will be there every step of the way. Hiring a documentation writer to advise and complete these guidelines can be the difference between a pharmaceutical drug passing or failing the CMC process, and thus up to billions of dollars in sales.

The Chemistry, Manufacturing and Control process is difficult, but when you hire with Essential Data a documentation writer will be with your company every step of the way. With the help of our technical writing experts, this regulatory process will be seamless and secure. At Essential Data Corporation, the quality of our work is guaranteed. Contact us today to get started. (800) 221-0093 or

Written by Ariana Sweany


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