Regulatory strategies require the most efficient route to attain your project goals. QMB collaborates to optimize compliance, accelerate product commercialization, and help you save both time and costs.
Strategic QMS Deployment
We tailor an end-to-end QMS solution for all quality stages. Ranging from QMS advisement to complete third-party vendor QMS deployment.
New Product Development
Act as a trusted partner that clarifies and defines regulatory requirements for submission approvals and clearances.
Quality Systems Compliance and Assurance
Tailor your quality system to align with your company's scale, operations, and needs. QMB can build or augment your QA team with our consultants. We help life science companies with specialized expertise and drive their projects to completion on time and on budget. Our QA support includes auditing services, remediation support (483s, FDA warnings, product recalls, adverse events reporting, CAPAs), and staff augmentation.
Your regulatory submissions require meticulous review for completeness and accuracy. Collaborate with QMB to highlight safety, efficacy, and regulatory adherence, enabling a swift and efficient clearance for your product to enter the market.
Technology acquisition is a common strategy many MedTech companies utilize. QMB can assist with product pathway assessment and review of your documentation to help mitigate future liability and risk and the burden of expensive remediation efforts.
Additional QMB Services
Organizational Transformational Strategies | Verification and Validation Support
QMS build and implementation. | eQMS migration and deployment
GXP (Good manufacturing, Clinical, Documentation Practices Training)
Clinical Trials Management | Lean 6 sigma training and support