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Who We Are
VIAM BIO specializes in project management for early-stage biotech and medical device startups. I bring proven expertise in strategic planning and operational execution, helping clients navigate regulatory complexities and achieve their commercialization goals
VIAM BIO Services
Strategic Planning
We help early-stage medical device companies develop clear, executable roadmaps from concept to commercialization. Our strategic planning includes clinical development pathway design, regulatory route mapping, realistic timelines and budgets, and milestone definition that keeps your team focused on what matters most. We ensure every stakeholder understands the journey ahead and has confidence in your ability to execute.
Regulatory Strategy & Compliance
Navigating FDA and international approval processes doesn't have to be overwhelming. We provide expert guidance on 510(k), De Novo, PMA, and IDE applications, ensuring your clinical protocols align with regulatory expectations from the start. Our services include managing pre-submission meetings, preparing submission-ready documentation, and implementing quality management systems that satisfy ISO 13485 requirements.
Risk Identification & Mitigation
Unforeseen risks can derail timelines and exhaust budgets. We conduct comprehensive risk assessments across clinical operations, regulatory compliance, supply chain, partner performance, and financial planning. Our proactive approach helps you identify potential obstacles before they become crises and implement practical mitigation strategies that keep your project on track.
Vendor & Partner Management
Your success depends on the right partners: CROs, testing labs, clinical sites, and contract manufacturers. We help you identify and vet qualified vendors, manage contracts, monitor performance, and maintain quality oversight. We act as your extended team, ensuring partners deliver on time and on budget while protecting your project timeline.
Clinical Trial Coordination & Management
We manage your clinical studies from protocol finalization through data lock, handling site selection and activation, patient recruitment, regulatory compliance, data quality oversight, and stakeholder communication. Our hands-on approach identifies and resolves problems quickly, keeping your trial on schedule, on budget, and focused on generating the data you need for regulatory submission.
VIAM BIO Insights
40%
Reduction in Project Timeline Risk
85%
Client Retention Rate
5+
Average Partner Relationships Managed Per Project
Why Choose VIAM BIO
1
Deep Industry Expertise
We specialize exclusively in early-stage medical devices, understanding the unique regulatory pathways and clinical validation challenges you face
2
Hands-On Partnership
We work alongside your team in the trenches, managing daily operations and solving problems in real-time during critical development phases
3
Risk-First Mindset
Our proactive approach identifies challenges before they impact timelines or budgets, giving stakeholders confidence in your execution
4
Tailored to Startups
We provide enterprise-level project management at a scale that makes sense for lean teams and limited resources.
