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One of the key elements of quality control in pharmaceutical manufacturing is cGMP compliance. As your product moves closer to market, cGMP requirements change and become more stringent. Download our whitepaper, FDA Guidelines for GMP of API to learn more.

Featured in this Whitepaper:

  • API and GMP overview
  • FDA API regulations including:
    laboratory controls, equipment, facilities, personnel and more
  • FDA guidelines including:
    documentation, distribution, packaging, validation, complaints, recalls and more
  • API guidelines for clinical trials
Dalton can support your cGMP API development at any stage, by reducing costs and timelines! We are experts in cGMP compliance and are FDA inspected, Health Canada approved, and MRA with EFA.

Visit our website to learn more.


Download the Whitepaper