we partner with combination products, drug, medical device, and biologics manufacturers to deliver

highly-skilled, specialized-knowledge resources for mission-critical projects including product launch, regulatory compliance, large-scale change, and process improvement.

Regulatory Consulting and Quality Systems Expertise for FDA-Regulated Industries

Providing strategic, on-demand support and tactical project management expertise through a roster of highly skilled, knowledge resources on demand. From product launch, to regulatory compliance, to large-scale change, to process improvement.

MISSION-CRITICAL

Through our proprietary process-driven approach and roster of highly skilled, specialty knowledge resources ready to be deployed when you need them, we partner with you on mission-critical projects that shape the safety and effectiveness of products that deliver cures, treatments, and disease prevention in the global marketplace.

PROJECT MANAGEMENT

Our consultants are producing members of your team, offering project management oversight while delivering straightforward and practical solutions that can be implemented quickly. We enhance internal expertise by using best-in-class tools to get the job done, and we transfer our knowledge and skillset to your internal team members along the way.

PROPRIETARY PROCESS

Using our proprietary process, qsnFLOW™, we jumpstart your project by rapidly deploying resources to multiple locations without sacrificing quality and consistency. Our network of highly experienced professionals allows us to quickly scale as needed – offering solutions that are flexible, scalable, and cost-effective.

Regulatory Compliance

Quality Solutions Now offers expertise in ensuring that clients meet regulatory requirements, including FDA regulations and ISO standards. Their consultants assist in navigating complex compliance landscapes, preparing for audits, and implementing quality systems that adhere to industry standards.

Process Improvement

They specialize in analyzing and enhancing existing processes to improve efficiency and effectiveness. Utilizing methodologies like Six Sigma and Lean Manufacturing, their team identifies areas for improvement, reduces waste, and implements strategies to optimize operations.

Project Management

Quality Solutions Now provides project management services that include planning, execution, and oversight of projects. Their consultants work closely with clients to develop strategic plans, manage resources, and ensure that projects are completed on time and within budget.

Quality System Development

They assist clients in developing robust supply chain strategies and quality systems. This includes supplier qualification, risk assessment, and the creation of procedures that ensure product quality and compliance throughout the supply chain.

Let’s Strengthen Your Compliance, Quality, and Operational Success Today

Expert Regulatory & Quality Consultants for Regulated Industries | QSN

Quality Solutions Now (QSN) has been working with our company for approximately 6 months now and the work that has been completed for us has been of the highest quality and accuracy. When I first contacted QSN early last summer and explained the type of support we needed, QSN managing partners quickly located several individuals within QSN that would be available either immediately or within a short period of time. QSN did not waste our time by sending someone we had to educate before that person could be productive and provide us what we needed.

Medical Device Manufacturer , Senior Director of Quality Assurance & Regulatory Affairs
International

PROCESS

Streamlined regulatory process development for pharmaceutical, biologic, and medical device manufacturers focused on FDA compliance and quality assurance.

Partnerships

TECHNOLOGY

Advanced digital technologies powering FDA submission workflows, QMS automation, and life sciences documentation management for faster, error-free compliance.

Excellence

EXPERIENCE

Decades of experience guiding life sciences companies through regulatory strategy, validation planning, and quality system implementation across global markets.

Trusted by Industry Leaders in Regulated Sectors