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Clients

Pharmefex serves clients that include pharmaceutical and biotechnology companies worldwide.  In particular, we specialize in assisting companies to accelerate the development and approval of recombinant proteins and cellular and immunotherapy products.  Clients range in size from smaller start-ups to multinational corporations. Over the last 4 years, we have successfully served the needs of more than 40 different clients around the world.  In short, pharmefex produces consistently high-quality results for clients of virtually any size and geography.  While we specialize in CMC support, we take pride in our depth of expertise in the following areas:

Early stage Support

  • CMC Strategy Development

  • RFP generation for CRO/CDMO selection

  • Transfer from academic labs to CMOs

  • Technical/CMC guidance

  • Project/program management

  • Outsourcing

  • Risk assessments

Late stage Support

  • Process and analytical method development consulting

  • CMO selection & Oversight

  • Technology transfer

  • Regulatory documents (IND, BLA, & other protocols) authoring and submission

  • Product and process characterization study design

  • Process and method validation

  • Product comparability 

  • Quality by Design