Qualification and Validation
Ensuring Compliance and Operational Excellence
Qualifications and Validation ensure that all processes, equipment and systems function effectively and meet regulatory standards in the life sciences industry. We assist life sciences companies with their Qualification & Validation throughout the product life cycle.
Why Choose BioBoston Consulting for Qualification & Validation?
Industry-Specific Expertise
Our team of experts has extensive experience in qualifications and validations across pharmaceuticals, biotech and medical device manufacturing. We understand the regulatory requirements and we offer custom-tailored services so that both your processes and equipment meet all required standards.
End-to-end Validation Solutions
Our services cover the entire validation process, from initial planning and protocol development through execution and final reportage. We ensure that your equipment, systems and processes are completely validated to regulatory requirements, reduce risks and guarantee product quality.
Regulatory Compliance Focus
Our validation and qualification activities are always in full compliance with relevant FDA, EMEA, cGMP, ISO and ICH standards. Our approach also ensures that one hundred percent of your processes and systems are compliant, reducing the risk of any issues or product recalls.
Customized Validation Plans
We tailor qualification and validation plans according to the special requirements of your facility, equipment or process–whether it be to validate a new piece of equipment or requalifying an existing system. Those solutions are custom crafted by our team to align with both your business needs and all relevant regulatory requirements.
Comprehensive Risk Management
This includes rigorous risk assessments to identify and contain potential problems before they turn into compliance issues. We aid you in implementing Corrective and Preventive Actions (CAPA) so that your quality and compliance are assured over time.
Our Qualification and Validation Services Include:
- Equipment Qualification (IQ/OQ/PQ)
- Process Validation
- Cleaning Validation
- Computer System Validation (CSV)
- Facility and Utility Qualification
- Validation Protocol Development
- Requalification and Periodic Review
- Ensure Compliance with BioBoston Consulting’s Qualification and Validation Services
Contact Us Today
Schedule a consultation to learn how BioBoston Consulting can support your qualification and validation needs and ensure the compliance and quality of your operations.
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