Gap Assessment
and Remediation
Identifying and Closing Compliance Gaps
Continuous active identification and remediation of compliance gaps are key to meeting the often-complex regulatory requirements in the life science industry. Gap Assessment & Remediation services from BioBoston Consulting offer clients tailored solutions that can make them detect and close compliance gaps efficiently enough to continue enjoying regulatory compliance and operational efficiency.
Why Choose Us for Gap Assessment & Remediation?
Comprehensive Assessment
Our experienced team executes stringent gap analyses to identify regulatory gaps in processes, systems, and documentation.
Strategic Remediation Plans
We create remediation plans that are tailored to facilitate easy and efficient detection of the deviated points and respond to each of the identified gaps to ensure compliance with the regulations.
Regulatory Expertise
We provide our customers with strategic guidance through our deep knowledge of regulation standards and requirements to help them deal with compliance issues.
Continuous Monitoring
Our remediation is supported and monitored continuously to make sure that it will be a success and sustainable in the first place.
Our Gap Assessment & Remediation Services Include:
- Compliance Gap Identification
- Remediation Plan Development
- Implementation Support
- Regulatory Documentation Review
- Training and Education
- Ongoing Monitoring and Support
Ready to Ensure Compliance and Operational Excellence?
Contact us today for more information on our Gap Assessment & Remediation services and how to help you address compliance gaps effectively.
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