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Bio Pharma Technical Consulting

Pharmaceutical Quality/CMC

CMC is an acronym for chemistry, manufacturing, and controls, an  FDA term used globally to describe the data for the manufacture and testing of a medicinal product. This term has now been replaced by Pharmaceutical Quality/CMC, which are crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.

CMC Expertise Provided

  • BPTC  experts in Tech transfer
    CDMO Selection & Management

    Select and manage contract manufacturing organizations on behalf of our clients. 

    We have partnered with many CDMOs and can adviise on the best path forward  on a case by case basis.  

  • bptc - experts in Process development
    Process Validation
    Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation.
  • BPTC  specialists in cell and gene therapy
    Development and Manufacturing Strategies 

    With a science-first approach to understanding your product, combined with first-hand insights of regulatory expectations and requirements, help support the successful design of your CMC plan — including process and formulation development, analytical development identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP), developing control strategies, establishing quality testing methods and reviewing validation protocols and reports

We will work with you to develop your strategy

Working with Tiffany Rau, who is experienced in regulatory strategy and CMC development will help you analyze and document the manufacturing processes, active substance and drug product characteristics, and testing to ensure the product is safe, effective, and consistent.

From early-stage development and at every point through commercialization, BPTC partners with you to tackle complex CMC development challenges. We ensure the regulatory authorities see the control and robustness of your process and product from a documentational and operational perspective. As your CMC consulting partner, we can smooth the path to marketing authorization application (MAA)/new drug application (NDA) approval and commercialization, balancing cost, risk, and speed to help you ensure quality manufacturing and effective controls for the health and safety of patients.

Photo of Tiffany D Rau expert on CMC strategy in Ireland

Tiffany D. Rau Ph. D

Tiffany -> Linked In »



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

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About BPTC 

Biotech consultancy with expertise in CMC, Cell and Gene Therapy, Process Development and Commercialisation, Compliance and Tech Transfer


Bio Pharma Technical Consulting  
Cork, T23 KW81 , Ireland 

 Our US Partner 

Tiffany Rau CMC consultant Ireland 
Rau Consulting LLC