One team across all stages, built for real execution
From early planning to commercialization, we plug in where experience matters most: quality, regulatory, and operational execution aligned to your stage, your urgency, and your risk.
Projects Delivered
Repeat Clients
Years of Experience
Countries Supported
650+ Senior Experts, including former FDA investigators
Supporting Your Development Journey
You’ve worked hard, secured funding, and set up your lab. Your team is growing, and you’re proud of those early wins. But the road ahead is still long, and you’re spending a lot of time sharing your vision with your team and keeping investors excited.
As you focus on research and testing before moving to human trials, safety and effectiveness are already on your mind, along with all the data you’re collecting. With the pre-IND submission coming up, the FDA is always in your thoughts.
We’re here to make things easier, helping you work more efficiently and overcome any roadblocks. Our experienced team is ready to help you make improvements that last. Let us support you as you face these challenges and reach your goals.
Biostatistics and Data Analysis
CTO Selection & Qualification
Lab Operations and Efficiency
CRO Selection & Qualification
Funding and Investment Strategies
Regulatory Strategy & Submissions
Research and Development (R&D)
Data Integrity and Software Implementation
Quality Assurance and Regulatory Compliance
Investigational Device Exemption (IDE) Application
Investigational New Drug (IND) Application
CDMO Vendor Selection Qualification & Oversight
Technology Transfer
Medical Writing
Recruitment
One-stop consulting services
Most teams do not need a large firm. They need the right senior support at the right moment, with clear ownership and steady follow-through.
We work across stages, but the approach is consistent: reduce uncertainty, strengthen evidence, and help your team move forward without chaos.
What teams need across the lifecycle
- Risk-based prioritization so teams stay focused
- Vendor selection, qualification, and oversight that prevents downstream surprises
- Right-sized QMS that supports speed and control
- Data integrity habits and system controls that build defensible evidence
- Clear remediation planning when gaps are identified
- Strong meeting and regulator communication support when stakes are high
Core services across all stages
These are the service areas teams most often use across multiple stages.
Project and Risk Management
Data Integrity and Software Implementation
Strategic Advising
Recruitment
Gap Assessment and Remediation
Regulatory Strategy and Submissions
Vendor Selection and Qualification
Quality Management Systems (QMS)
Quality Assurance and Regulatory Compliance
Health Authority Meeting Support
What you get from BioBoston across the lifecycle
- A clear plan that prioritizes what matters most, without overbuilding
- Practical risk and program management support that keeps work moving
- Vendor selection and qualification support that strengthens oversight and evidence
- QMS and compliance improvements that teams can actually sustain
- Data integrity and software implementation support to reduce compliance risk
- Regulatory strategy and submission support aligned to your stage and goals
- Health authority meeting support, including messaging alignment and readiness coaching
We propose the right expert path
We recommend the best-fit senior expert or small team.
Execution with clear checkpoints
We deliver in visible steps so progress stays measurable.
Tell us what is happening
A short intake to understand urgency, constraints, and risk.
Simple engagement model
Not sure where to start? We can help you prioritize in one call
If you share what you are building and what is pressuring your timeline, we will help you choose the right next step.