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CMC Regulatory Process

CMC Regulatory Process

Before the general population can use, obtain, and consume pharmaceutical medicine, it must go through a lengthy regulatory procedure. This ensures both the safety of the drug and the safety of its manufacturing process, which in turn helps to ensure consumers’ safety. 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 that describes the regulatory process pharmaceutical drugs go through to be approved by the US Food and Drug Administration. Pharmaceutical medications must pass this process in order to be regarded as both effective and safe for the user.

The CMC method is applicable to both the medicine and the manufacturing company that makes it. The process is applicable to the entire product life cycle, starting in the drug candidate selection phase.

The process includes a thorough evaluation of the following:

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

Documentation Writers and the CMC Regulatory Process

Moreover, the CMC process involves a great deal of lengthy paperwork and documentation; no surprise there. 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 writing the necessary paperwork and technical documentation. Technical and documentation writers will ensure that every detail of the pharmaceutical drug is written down in the CMC regulatory process, ensuring that the pharmaceutical drug can be approved by the FDA. 

Furthermore, 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. Your business can save time, money, and headaches by hiring a documentation writer to complete this paperwork efficiently and accurately.

To Master CMC, Hire With EDC!

EDC’s technical writers can be a major asset to any business seeking to ensure their medications pass the CMC process, as these writers have the knowledge and skill needed to efficiently create the necessary documentation.  In conclusion, a writer provided by Essential Data Corporation works closely with the contract manufacturing organization to give them the documentation they need to show their medication is ready for public use. In addition, they abide 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