Chemistry, Manufacturing and Controls (CMC) Submissions

KBI Biopharma’s strong background in biopharmaceutical product development enable us to collaborate closely with in determining what data is most appropriate from a regulatory perspective at various stages of product development.

Our technical team has extensive experience in generating submission-ready data and reports for a client’s Chemistry, Manufacturing and Controls (CMC) regulatory documentation.

KBI Biopharma is flexible in working with any format our clients require in preparing data and reports, so that compilation of the CMC is a smooth process.

The KBI team has successfully supported submissions for large pharma and also smaller virtual companies and can work collaboratively with regulatory teams from any size organization and under any scenario.

KBI Biopharma’s facility DMF and a Site Master File are available to KBI clients for regulatory purposes.


Support services include:

  • Writing and/or review of the CMC
  • Quickly responding to questions from regulatory reviewers on behalf of our Clients
  • Providing regulatory inspection support
  • Providing facility information for regulatory submissions

KBI has the right combination of strengths; excellent technical expertise and project management, quick turnaround on deliverables and a high level of integrity to advance our project and reach our milestones. Our CMC team was very happy with the outcome of our collaboration with KBI.

UCB Celltech