FDA Inspection Readiness
Be Prepared for Regulatory Scrutiny
Preparation for regulatory inspections is the most effective way to avoid delay and be compliant. BioBoston Consulting through its Inspection Readiness services assist clients in preparing and navigating regulatory inspections with confidence. Our former FDA investigators will guide you through mock inspections and interact as they would if it were a real inspection with your team.
Why Choose Us for Inspection Readiness?
Experience and Expertise
Our team of former FDA investigators has vast experience in preparing clients for inspections across several regulatory agencies and jurisdictions.
Comprehensive Preparation
We conduct mock full-scale inspections and gap assessments to reveal improvement areas and ensure clients are prepared against regulatory scrutiny.
Regulatory Insights
We keep ourselves abreast of changing regulatory trends and expectations. We provide insights and guidance that enable our clients to be aligned with requirements.
Confidence Building
We want to instil confidence in the teams of our customers, so that they are best positioned to answer questions from an inspector and can thus demonstrate compliance during inspection.
Our Inspection Readiness Services Include:
- Mock Inspections and Gap Assessments
- SOP Review and Development
- Training for Inspection Readiness
- Document Management and Organization
- On-Site Support During Inspections
- Post-Inspection Follow-Up and Remediation
Ready to Face Inspections with Confidence?
Contact us today to learn more about our Inspection Readiness services and how we can assist you to be prepared for regulatory inspections.
All Services
- Quality Assurance and Regulatory Compliance
- Investigational New Drug (IND) Application
- Regulatory Strategy & Submissions
- Investigational Device Exemption (IDE) Application
- Vendor Selection & Qualification
- Project & Risk Management
- Technology Transfer
- Quality Management Systems (QMS)
- Gap Assessment and Remediation
- Funding and Investment Strategies
- Research and Development (R&D)
- Biostatistics and Data Analysis
- Lab Operations and Efficiency
- Medical Writing
- CDMO Vendor Selection Qualification & Oversight
- CRO Selection & Qualification
- CTO Selection & Qualification
- Data Integrity and Software Implementation
- Clinical Operations
- Clinical Trial Monitoring
- FDA Inspection Readiness
- Internal and Supplier Audits
- Regulatory CMC Support
- Qualification and Validation
- GxP Training
- Computer System Validation (CSV)
- Strategic Advising
- Process Optimization
- Health Authority Meeting Support
- Recruitment