Consult with
Biotech Experts
Fast Forward to Success
Our expertise spans across clinical and commercial biologics and gene therapy manufacturing, tech transfer, process validation, risk assessments, technical writing, regulatory inspections, business development, project management, alliance management, and more.
We offer guidance and support for short- or long-term projects to suit your needs.
Contact us to schedule a free consultation.
How We Can Help You
We offer expertise in a wide range of subject matters in the biotechnology and pharmaceutical arena:
General Areas of Expertise
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Drug substance and drug product
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Clinical and commercial manufacturing
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Cell culture and cell banking
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Purification and column lifetime validation
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Facility start-up
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Regenerative medicine
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Cell and gene therapy
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Viral vector manufacturing
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Plasmid DNA
Technology Transfer
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Project Management
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Risk assessments
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New product introduction
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Process validation protocols/reports
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Facility fit assessments
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Process flow diagrams
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Aseptic process validation
Chemistry, Manufacturing, and Controls (CMC)
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Program management
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Product lifecycle management
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Cross-contamination control strategy
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FDA pre-approval and routine inspections
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FDA Type B & C meetings
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US & international regulatory agency inspection support
Business Development
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Prepare proposals for prospective clients
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Contract negotiations
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Pricing strategies
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Sales and marketing
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Create advertising materials
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Plan, coordinate and staff vendor booths at tradeshows
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Meet with prospective clients to share services and capabilities
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Develop initial relationships with clients
Vendor Management
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Manage suppliers and CMOs
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Identify, assess, and establish new vendors for raw materials, plasmids, and components
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Create governance structure and business processes
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Establish KPIs