Quality Solutions Now
Quality Solutions Now specializes in regulatory consulting, quality systems, and product development for FDA-regulated industries, including medical devices, biologics, and pharmaceuticals. They leverage proprietary processes and a team of highly skilled professionals to deliver flexible, scalable, and compliant solutions, guiding clients through complex regulatory landscapes, patent protections, and product lifecycle management. Their mission is to ensure the safety, effectiveness, and marketability of healthcare products worldwide.
Industries
Nr. of Employees
small (1-50)
Quality Solutions Now
475 Brickell Avenue, Suite 1707 | Miami, Florida 33131
Products
qsnFLOW™
A proprietary process-driven approach that rapidly deploys resources for project management, ensuring quality and consistency across multiple locations.
qsnFLOW™
A proprietary process that accelerates project initiation by deploying resources rapidly across locations while maintaining quality and consistency.
Project Management Expertise
Provides oversight and coordination for projects, including change management, project leadership, and facilitation.
Project Management
Offers oversight and coordination for projects, including leadership, facilitation, and stakeholder communication.
Regulatory Compliance
Provides support for regulatory affairs, quality system development, and compliance management for medical devices and drugs.
Regulatory Compliance
Offers support in regulatory affairs, quality system development, and compliance management for medical devices and drugs.
qsnFLOW™
A proprietary process-driven approach that rapidly deploys resources for project management, ensuring quality and consistency across multiple locations.
qsnFLOW™
A proprietary process that accelerates project initiation by deploying resources rapidly across locations while maintaining quality and consistency.
Project Management Expertise
Provides oversight and coordination for projects, including change management, project leadership, and facilitation.
Project Management
Offers oversight and coordination for projects, including leadership, facilitation, and stakeholder communication.
Regulatory Compliance
Provides support for regulatory affairs, quality system development, and compliance management for medical devices and drugs.
Regulatory Compliance
Offers support in regulatory affairs, quality system development, and compliance management for medical devices and drugs.
Services
On‑demand regulatory strategy, audit readiness, remediation, and QMS development for FDA‑regulated manufacturers and combination product developers.
DHF gap analysis, DHF assembly/remediation, traceability matrix development, and design verification/validation support aligned with applicable device regulations.
Development and execution of IQ/OQ/PQ protocols, commissioning support, validation master planning, and qualification of manufacturing and laboratory equipment.
Packaging concept, feasibility, development and validation for sterile and non-sterile products, including fragility assessments, ISTA/ASTM/ISO distribution testing, aging studies, sealing process development, and packaging conversions.
Thermal pack‑out design, datalogger studies, distribution lane qualification, and equivalency strategies to validate controlled temperature shipping systems.
Support for selection, installation and validation of packaging automation, tooling, thermoforms, form/fill/seal equipment, induction sealing, and digital folding-carton printing workflows.
On‑demand regulatory strategy, audit readiness, remediation, and QMS development for FDA‑regulated manufacturers and combination product developers.
DHF gap analysis, DHF assembly/remediation, traceability matrix development, and design verification/validation support aligned with applicable device regulations.
Development and execution of IQ/OQ/PQ protocols, commissioning support, validation master planning, and qualification of manufacturing and laboratory equipment.
Packaging concept, feasibility, development and validation for sterile and non-sterile products, including fragility assessments, ISTA/ASTM/ISO distribution testing, aging studies, sealing process development, and packaging conversions.
Thermal pack‑out design, datalogger studies, distribution lane qualification, and equivalency strategies to validate controlled temperature shipping systems.
Support for selection, installation and validation of packaging automation, tooling, thermoforms, form/fill/seal equipment, induction sealing, and digital folding-carton printing workflows.
Expertise Areas
- Regulatory compliance and submission support for devices and combination products
- Quality management system (QMS) design and remediation
- Design controls and DHF remediation
- Risk management and FMEA-based processes
Key Technologies
- IQ/OQ/PQ equipment qualification
- Computerized systems validation (CSV) for EDMS/LIMS/QMS
- Thermal mapping, datalogger studies and cold‑chain packaging
- Sterilization validation methods (ethylene oxide, gamma, e‑beam)
News & Updates
Partner Testimonial
A testimonial from a senior director of quality assurance & regulatory affairs at a medical device manufacturer praising the high quality and accuracy of work done by QSN.
Partner Testimonial
A testimonial from a senior director of quality assurance & regulatory affairs at a medical device manufacturer praising the high quality and accuracy of work done by QSN.