Quality Management
Systems (QMS)
Compliance with regulatory standards achievable
In life sciences, QMS is crucial. It makes compliance with regulatory standards achievable, improves operational efficiency and pushes for continuous improvement. In the realm of the life sciences we provide expert consulting sevices on quality management systems (QMS).
Why Choose BioBoston Consulting?
Industry-Specific Experience
We know the peculiar challenges industry and different national regulatory systems pose, bringing this experience to bear on every solution we build. Our team has worked extensively with drug, biotech and medical device companies.
Compliance with Global Standards
Our QMS is designed to meet the latest regulatory requirements so you don’t have to worry about it. We ensure that our system is in alignment with global standards as dictated not only by the FDA but also by EMA, ISO 13485, etc. The result is a solution that meets current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
Customized QMS Solutions
We understand your company’s individual needs. Whether you ‘re starting from scratch with a QMS or bringing one up-to-date, our customized services make your quality processes more effective, save on risk exposure, and increase operational efficiency wherever possible.
The Pursuit of Continuous Improvement
Our QMS is different. It’s not just about keeping up with regulatory changes, it’s about ongoing improvement. We guide you to build a quality environment where products can be made more secure and errors minimized—all to enhance business performance as well.
Systems That Are Scaled And Flexible
What we give you are not rigid systems which will not grow with the company’s needs. In response to the requirements of each individual company, our QMS services are designed to be scalable and flexible.
Our QMS Services Include:
- Design And Implementation Of Quality Management Systems (QMS)
- QMS Audits and Gap Assessments
- Document Control and Management
- Training and SOP Development
- CAPA (Corrective and Preventive Action) Management
- Risk Management and Compliance Monitoring
- BioBoston Quality and Compliance
Contact Us Today
Please call for a consultation with BioBoston Consulting on your Quality Management System requirements.
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