OUR SERVICES
Your success is our success
The BRC global team are bioprocess technology consultants who share a common goal; to improve and support the management of biologics programs from concept through to development and GMP manufacturing. We help our clients successfully deliver product in support of Phase I-III human clinical trials and use our extensive Contract Development & Manufacturing Organization (CDMO) experience to effectively manage third-party service relationships on your behalf.
Business Operations
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Corporate strategy and value creation
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Capital formation and investor relations
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CMC technical due diligence
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Alliance management and strategic growth
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Startup governance
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Innovation management
Technical Operations
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Request for Proposal (RFP) management
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Technical program management
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Technology transfer planning and execution
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Oversight of process and assay development and optimization activities
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Bioprocess troubleshooting and investigations
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Managing scale-up, engineering and GMP manufacturing operations
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External clinical and commercial manufacturing
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Facilities design and conceptual engineering
Commercial Operations
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Due diligence, product vetting and overall business management support
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Auditing, compliance oversight and regulatory submission support
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Managing of complex virtual service chains on behalf of sponsor companies
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Business development, marketing and sales
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Product development roadmaps
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Clients’ portfolio management
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E-Technology development, programming, and coding custom application solutions for biopharma applications
Clinical Research Operations
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Clinical project management including management of actuals to forecast
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Coordination of cross-functional clinical and regulatory team meetings
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Compliance management
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Oversee study start-up activities
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Study progress monitoring
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Status update reports to senior management and sponsors
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Manage study documentation
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Ensure accuracy and completeness of study data
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Oversee data management activities
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Facilitate study close-out activities
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Maintain effective relationships with study sponsors, agencies, and stakeholders
