Tiffany Rau Consulting

Your Partner in Biologics

Providing strategic solutions and expertise to guide you through the challenges associated with Late Discovery, Early Development, Late Development/Commercialization, Regulatory Submission to Approval, across all the essential drug development workstreams



  • CMC consultant
    We have in-depth experience and expertise in developing CMC and manufacturing strategies for large molecule. We have also managed and overseen the CMC development and cGMP manufacturing from pre-clinical into late-stage development.
  • Cell and gene Therapy consultant
    Cell & Gene Therapy  
    With expertise across the cell and gene therapy life cycle our range of approaches will help tackle the challenges you might face in the development of cell and gene therapies. We’ll work with you to accelerate your projects, helping your cell and gene therapies to be safer, more effective, scalable and affordable.
  • Biotech process development consultant
    Process Development
     Integrating upstream and downstream process development strategies for a variety of expression systems- mammalian, microbial and cell free. Products include therapeutic antibodies, difficult to express protein and molecules, cell and gene therapies, and exosomes, etc
  • Biotech Technology Transfer consultant
    Technology Transfer
    Tech transfer is a complex operation carrying business, regulatory, product quality, and technical risks. Each TT case is potentially different and requires a tailored approach. Thats where Rau Consulting can assist and mentor you and your company.
  • Clinical and commercial manufacturing consultant
    Clinical and Commercial Manufacturing
    Commercial manufacturing is characterized by process and cleaning that are operated with full validation, as are the analytical methods. Clinical does not require process, cleaning or analytical methods to be validated
  • Project Management
     GAMP 5 - A risk-based approach to compliant GxP computerized systems. The newly revised EU GMP Annex 11 includes an update to 21 CFR Part 11 which brings a more pragmatic approach to compliance in a GMP environment. We can empower your team with the latest that GAMP 5 has to offer.


Principal Consultant

Tiffany D Rau, Ph. D, owner and Principal Consultant of Rau Consulting is an expert in bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing.

Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges.
Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems

Tiffany has recently been appointed Adjunct Professor in the School of Biochemistry and Cell Biology at University College Cork, Ireland, where she is currently lectures on a part time basis.  more

photo of Tiffany D Rau Biotech Consultant

Tiffany D. Rau Ph. D

Founder and Principal Consultant

Tiffany - Linked In »





Supplier and Internal Audits
Process Development
Scale-up and Scale down Models
Design for Manufacturability
Process Characterization
Bioreactor Development
Facility Design & Startup
Regulatory Compliance




Expert and leader in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of bio pharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech


Rau Consulting, LLC