BioBoston Consulting

Preclinical

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.(more subtabs/services to be added below the introduction text, after grouping) 

Biostatistics and Data Analysis

Quality Management Systems (QMS)

Vendor Selection & Qualification

Gap Assessment and Remediation

Project & Risk Management

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

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