Our Clients
Pharmefex partners with pharmaceutical and biotechnology companies worldwide, helping them accelerate the development and regulatory approval of recombinant proteins, cellular therapies, and immunotherapy products. Our clients range from innovative start-ups to global corporations. Over the past decade, we have successfully supported more than 128 clients across the globe, contributing to over 17 regulatory submissions and securing 5 commercial approvals.
Renowned for delivering high-quality results across diverse markets, Pharmefex specializes in Chemistry, Manufacturing, and Controls (CMC) support while offering deep expertise in key areas critical to product development and regulatory success.
Early Stage Support
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Process and analytical method development consulting
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CMO Selection & Oversight
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CMC Strategy Development
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RFP generation for CRO/CDMO selection
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Transfer from academic labs to CMOs
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Technical/CMC guidance
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Project/program management
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Outsourcing
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Risk assessments
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Phase Appropriate Quality Systems, investigations and quality audits
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Statistical design and analysis
Late Stage Support
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Inspection Preparation and Management
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Compliance audits, gap assessments and remediation
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QA, QC, Qualification & Validation
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Technology transfer, scale-up & manufacturing
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Regulatory documents (IND, BLA, & other protocols) authoring and submission
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Product and process characterization study design
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Process and method validation
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Product comparability
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Quality by Design
