BpFx Solutions

Welcome to BPFx Solutions

We help biopharmaceutical innovators overcome CMC drug product challenges – from discovery through commercialization.  With over 25 years of leadership in drug delivery and sterile injectable development, we have guided more than 20 medicines to critical CMC milestones.  Let us help you solve your development challenges and accelerate your product timelines.  

Strategic ConsultancyTechnical R&D ConsultancyDue diligence and IP support
 Creation of enterprise level strategies to support end to end drug product needs across clinical and commercial markets. We understand modality and indication-based drivers of product development providing options that meet technical clinical, commercial, quality, regulatory, delivery and supply chain requirements.



 
 
We can help you achieve your target product profile through QTPP design of the drug product customized based on development stage, preclinical, clinical investigation or market applications.  We employ integrated development approaches and support regulatory submissions whilst optimizing cost, quality and time considerations for your needs.   We can help you solve your technical challenges through the use of structured root cause analysis approaches using lean and six sigma tools.                                             
We can support your due diligence investigations with deep technical expertise in drug delivery, drug formulation, product, process and end to end development requirements; and provide SME support for IP evaluations/ investigations.


 







Contact Information:

https://www.linkedin.com/in/myrnamonckphd

Tel: +1 (610) 470 – 4692

Email: info@bpfxsolutions.net

Please connect with via phone or linkedin for an introductory call.   

BpFx Solutions

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