Chemical Manufacturing and Controls

Ensuring everything is as expected, every time

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What to Know

Chemical Manufacturing and Controls, or "CMC," describes the regulations that assure a drug meets standards, labeling requirements, and intended use confirmation. CMC also serves as a quality check between clinical trial formula and the final product.

How We Can Help

I3 infotek CMC consultants are degreed experts in pharmaceutical sciences and related chemical and biological fields. Experienced and focused, our regulatory specialists can provide:

  • Development of RA strategy and work plan
  • Preparation of complete registration casebook for internal approval and timely submission
  • Acting as a liaison between regulatory bodies and company (i.e., registration, sample assessment, regulator inquiries, review committee sessions)
  • Expedite registration process
  • Create, document, and maintain a complete file
  • Develop and prepare SOPs and post-launch procedures
  • Inform and train in-house staff for ongoing product compliance