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ABOUT
us
At QTeam LLC, we specialize in providing subject matter expertise to both established and start-up pharmaceutical and biopharmaceutical companies. Our focus is on quality and compliance, and we offer flexible solutions that can enhance your team or provide specialized expertise as needed.
What sets us apart is our customized approach. We understand that every organization has unique needs, so we work closely with you to tailor our services to fit your specific requirements.
By partnering with QTeam LLC, you gain access to a team of seasoned professionals who can seamlessly integrate into your organization and help you navigate the complex challenges of the industry.
our capabilities
QTeam LLC is a distinguished consulting firm that specializes in providing comprehensive and tailored solutions to the pharmaceutical and biopharmaceutical industry. Our mission is to assist companies in establishing, monitoring, and enhancing quality and compliance strategies to meet and exceed the stringent regulatory standards set by global regulatory agencies. Our demonstrated expertise covers aseptic and non-aseptic drug products and medical devices.
At QTeam LLC, we understand the unique challenges faced by our clients. That's why our team of highly skilled experts is dedicated to supporting organizations in all aspects of regulatory compliance. We offer a wide range of services designed to address the specific needs of the pharmaceutical and biopharmaceutical industry.
At QTeam LLC, we firmly believe in the importance of continuous improvement and staying up-to-date with the latest regulatory developments. We are committed to helping our clients navigate the complex regulatory landscape and achieve and maintain compliance with the highest industry standards.
Quality Systems
Our team excels in the implementation of current Good Manufacturing Practices (cGMPs), which are vital in maintaining the quality and safety of pharmaceutical products.
We assist our clients in establishing robust systems and processes that comply with cGMP requirements, ensuring that they consistently deliver human and animal health drug products of the highest quality.
Independent (Third Party) Support for Regulatory Compliance Mitigation
One of our core areas of expertise lies in assisting well-established companies in mitigating areas of opportunity that are identified during regulatory inspections.
With a decade of experience working closely with manufacturing sites under Warning Letters from the US Food and Drug Administration (FDA) or assisting firms with critical findings from the European Medicines Agency (EMA) and other global regulatory agencies, QTeam LLC possesses the expertise required to tackle these challenges and allow you to focus on what you do best.
Audits and Inspections
In addition to mitigation, we can also support your organization in preparing for audits and inspections conducted by regulatory authorities. We guide our clients through the entire process, offering comprehensive support and guidance to ensure they are thoroughly prepared and confident in their compliance efforts.
Our team conducts thorough assessments, identifies areas of improvement, and formulates effective strategies to address any gaps or deficiencies.
TRAINING
At QTeam LLC, we firmly believe in the power of sharing our expertise and transferring our knowledge base to benefit our clients. We understand that it is not enough to simply provide consultation services - we go above and beyond by offering comprehensive training solutions tailored to your specific needs.
Whether it's on-site or remote, we are fully equipped to provide training to your team. Our experienced trainers will guide your employees through interactive sessions, ensuring that they gain the necessary skills and knowledge to excel in their roles.
Coaching
In addition to training, we also offer dedicated, side-by-side coaching to assist in the development of your talent. Our experts will work closely with your team members as they perform their roles and responsibilities, in the areas of quality and compliance. This personalized approach allows for targeted improvement and ensures that your team is equipped with practical applications of industry standards.
By investing in our training and coaching services, you are not only enhancing the capabilities of your team members, but also fostering a culture of continuous learning and professional growth within your organization.
Other Key Core Areas of Expertise
In addition to cGMP compliance, we specialize in various other areas crucial to the pharmaceutical and biopharmaceutical industry.
Our proficiency includes corrective action and preventive action (CAPA) management including CAPA effectiveness checks, performing and reviewing deviation and complaint investigations, reviews of batch records, qualification and validation packages, effectiveness of laboratory systems controls, and verification of good documentation practices with a strong emphasis on data integrity.
How Can we Help You?
Quality Systems
We establish or assist in enhancements of your existing quality systems as needed aligned with current Good Manufacturing Practices (cGMPs)
Quality Audits
We perform quality systems audits against all applicable global cGMP regulatory requirements.
Inspection Readiness
We provide colleague coaching on what to expect and how to conduct an inspection readiness program. We can assist in your preparation for audits and inspections.
Corrective Action and Preventive Action (CAPA)
We excel in CAPA effectiveness verification specifically regulatory agency commitments made as a result of a regulatory inspection.
Deviation Investigations
We can assist in writing, reviewing or assessing deviation investigations against established standard operating procedures (SOPs)
Quality Culture
We provide assistance in evaluating your quality culture and recommend strategies for continuous improvement
Quality Risk Management
Depending on your needs, we can help establish your Quality Risk Management program or review and provide feedback on your current program
