Commercialization Services | BioBoston Consulting

BioBoston Consulting

Commercialization

ASSISTING WITH YOUR ONGOING QUALITY CHALLENGES 

As you near the end of clinical trials and receive approval to sell your drug, or if you’re a medical device company with 510(k) clearance, you’re likely preparing to scale up production and enter the market. You might also be getting ready for upcoming regulatory inspections. This is where the real work begins—ensuring your product stays competitive and compliant. 

Whether you’re focused on selling your product, ramping up manufacturing, maintaining regulatory compliance, expanding into new markets, conducting post-market monitoring, or managing medical affairs, we’re here to support you after approval. We help you keep an eye on product safety and build a strong culture of quality within your organization. 

Clinical Operations

Clinical Trial Monitoring ​

Regulatory Strategy & Submissions

FDA Inspection Readiness

Recruitment

Process Optimization ​

Internal and Supplier Audits

FDA Inspection Readiness

Gap Assessment and Remediation

Regulatory Strategy & Submissions

Computer System Validation (CSV)

Quality Management Systems (QMS)

Strategic Advising ​​

Project & Risk Management

Qualification and Validation

GxP Training ​

Vendor Selection & Qualification

Quality Assurance and Regulatory Compliance

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