Ark rivers
We are a consulting firm that enables biotech, pharmaceutical and medical device companies achieve their goals
we are known for
Strategic Planning & Implementation
Developing a plan is just as important as being able to execute one . . . we deliver on both!
Project & Program Management
We collaborate with you to set the charter, lead the team, leverage tools and templates, assess and mitigate risks, communicate status – champion to completion
Business Transformation
Change is the only constant . . . we utilize structured methodologies to develop the path and walk with you to realize the transformation
our latest work
Strategic Planning & Implementation
- Global strategic infrastructure investment plans for labs, manufacturing facilities & warehouses
- Network evaluation and selection of CDMOs for biologics pipeline asset
- Pipeline portfolio plan for products from pre-clinical through launch for CMC and regulatory
- Capacity expansion scenarios leveraging single-use technologies for CDMO
- Expansion plan with market conditions evaluation to extend business into Biosimilars
Project & Program Management
- Biologics manufacturing facility expansions, QC lab relocations, haz-mat and GMP warehouse
- Front-end feasibility and conceptual design projects for antibody and gene therapy facilities
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Regulatory filings with approvals for a rare disease franchise
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System design, installation and startup for commercial manufacturing of an antibody therapeutic
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Antibody drug conjugate (ADC) NDA submission, process validation, and production batches
Business Transformation
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Enterprise-wide transformation initiative development, prioritization, and execution for 2X output
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Spearheaded new ‘Ways of Working’ initiative, with a focus on change management
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Vision and roadmap for PMO by to improve performance and support growing pipeline
- Transition facility and operations from clinical to commercial manufacturing
we work with you
Our goal is to deliver standout results using a simple, practical, and hands-on approach that’s perfect for the unique industry challenges.
We understand your unique needs, bring our expertise to the table, tailor the solutions and take ownership of our projects.
We believe that working closely together and co-creating with you is key to driving innovation and success.
we have worked with
