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QC Excellence
Improving Your Compliance, Excelling Your Quality
Quality You Can Rely On
Quality Excellence Consultants is a global consulting firm based in New York City, with additional offices in Michigan and Europe. We specialize in all areas of the pharmaceutical industry, offering expertise in cleanroom design, sterility assurance, aseptic processing, environmental control, and NDA/ANDA filings. Our comprehensive services cover the full range of GMP, GLP, and GCP quality assurance and quality management needs.
We work closely with you to understand your requirements, develop tailored corrective actions where needed, and support you in preparing regulatory responses, filings, and inspection readiness.
Our offerings include specialized training programs, remote and on-site audits, batch manufacturing certifications, and NDA / ANDA review services.
Data Integrity (DI) Audits and Training
QC Excellence Consultants brings extensive experience conducting Data Integrity (ALCOA+) audits across the globe, including in the US, India, and China. Beyond identifying gaps, we deliver actionable plans to help you close them and reinforce your Quality System.
We offer targeted training for all levels of technicians and operators on Data Integrity (DI), enhancing understanding of ALCOA and ALCOA+ principles. Key elements include:
Attributable: Traceable data to the individual responsible.
Legible: Data must be readable and permanent.
Contemporaneous: Recorded at the time of execution.
Original: First-recorded source data.
Accurate: Complete, consistent, and truthful data.
Additional attributes ensure records are Complete, Consistent, Enduring, and Available throughout their lifecycle.
With increasing regulatory focus on Data Integrity from FDA, EMA, WHO, TGA, and others, compliance with standards like 21 CFR 211, 21 CFR 58, and EudraLex is essential. Our services help you implement robust controls to meet these regulatory requirements and uphold the highest standards in your quality documentation and data integrity practices.
Welcome to QC Excellence
Our Services
Welcome to our services section. Here, we offer a range of comprehensive solutions to meet the needs of pharmaceutical manufacturers. Our services are designed to ensure compliance with regulations, provide training, and deliver effective regulatory responses.
As Subject Matter Experts, we pride ourselves with the services we provide to our clients. Our experts continue their personal growth journeys through professional affiliations across PDA, ISPE and other venues.
Compliance Audits
Our compliance audits are conducted by experienced professionals who specialize in the pharmaceutical industry. We thoroughly assess your operations and processes to identify any gaps or areas of improvement. By partnering with us, you can ensure that your organization meets all regulatory requirements and maintains the highest standards of quality.
Comprehensive compliance audits in various areas:
- Full cGMP
- Customer Audits
- Data Integrity
- Manufacturing Compliance
- Aseptic Techniques
- Sterility Assurance
- Cell and Gene Manufacturing and Testing
Our experts provide practical recommendations to help you improve your compliance and avoid FDA and other regulatory compliance issues.
Training
At Quality Excellence Consultants, we understand the importance of continuous learning and development in the pharmaceutical industry. Our training programs are tailored to address the specific needs of your organization. From GMP training to quality management systems, we offer comprehensive training solutions to enhance the skills and knowledge of your workforce.
Our top programs are listed below:
- Annual GMP Training
- Device Design History Files
- Aseptic Compliance
- Sterility Assurance
- Laboratory Investigations
- Manufacturing Investigations
- Regulatory Audits Handling
We also develop any program needed for your firm to achieve compliance.
Regulatory Responses
Dealing with regulatory authorities can be complex and time-consuming. Our team of experts is well-versed in regulatory affairs and can assist you in preparing effective responses to regulatory queries and inspections. We work closely with you to ensure that your organization is well-prepared and can demonstrate compliance with regulatory requirements.
Our Warning Letters & 483 Response Management Team
Is a highly dedicated Compliance Team that will assist you in handling the regulatory response, suggest the most robust corrective- preventative actions, and effectiveness checks needed to avoid reoccurrence of the regulatory findings.
We have experts with significant prior FDA experience, whether working directly for FDA, or industry experts to tailor your needs. They have extensive experience in helping clients with the remediation plans and restarting manufacturing operations.
All about Quality Excellence
Quality Excellence Consultants is a global consulting firm headquartered in New York, USA . We offer full range of GMP, GLP, GCP Quality Assurance and Quality Management services.
We will understand your need, formulate, and propose corrective actions, where warranted, and assist you in preparing regulatory responses or prepare for regulatory inspections. We offer “hands-on” Cleanroom training, including Airflow Visualization Studies, audit of Cleanroom Practices and Aseptic Techniques.
As a leader in the industry since its inception, Quality Excellence has a seasoned team with a wealth of knowledge and experience in everything related to the manufacturing of pharmaceutical products. We’re committed to providing our clients with high quality services.
The industry is constantly changing, we work closely with our clients to help them improve and maintain compliance, and excel in their journey.
Contact QC Excellence
Looking for top-notch services? Turn to QC Consultants for all your compliance needs.
We offer a range of services, including custom training, audits, FDA prep., to ensure that your operations meet industry standards.
Contact us to learn more about how we can help you succeed.
866 United Nations Plaza
Suite 445
New York, NY 10017