We Plan, Implement and Support

Sustainable Compliance
From Documentation To Testing

Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training, Automation, Technical Support, Environmental Health & Safety

Schedule An appointment

Phone

(787) 418-0240

Email

info@wearequality.co

Office

Ave. Alejandrinio C-5, Guaynabo, P.R. 00971

Hours

Monday-Friday:
8am – 5pm

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IMPROVEMENTS & INNOVATIONS

Our improvements are based on the Quality Risk Management approach to validated the controls of regulated industries. We innovate solutions to increase compliance and process effectiveness.

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REMEDIATION PLANS

Our advanced remediation methodologies result in a sustained compliance that guarantees the high level of efficiency and ongoing service you demand and expect.

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CONTINUOUS SUPPORT

Our clients’ goals are ours goals. We are a preferred service provider in consulting, advice and support for Regulatory Compliance, Quality Operations, Quality Systems and more.

We are Experts in Regulatory Requirements

The Quality Consulting Group is a specialty consultant company that supports the manufacturing, pharmaceutical, biotechnology, food, recycling, fuels and oils and medical device industry. Services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training, Automation, Technical Support, Environmental Health & Safety, among others.

Starting as individual services provider since 2002; Quality Consulting Group has supported clients, implementing the latest standards in Validation Guidance, ICH Guidelines, Process Excellence and Risk Management tools.

QUALITY OPERATIONS SERVICES

We have extensive experience in quality services. Our services in this category include: Risk Assessment, APR’s, Change Controls, Investigations, Product Quality complaints, Project Management and more.

VALIDATION SERVICES

In the area of Validation we provide an a wide range of service options including: Technology Transfers, Manufacturing Controls, Process and Cleaning Validations, Equipment Qualifications (IQ/OQ/PQ).

REGULATORY COMPLIANCE

Our expertise in Regulatory Compliance includes: NDA documentation, Filings and Post Approval Changes. PAI Readiness, Audit Management and Audit Response & Monitoring.

FACILITIES / UTILITIES

Environmental Health & Safety, Water Systems, Corrective and Preventive Maintenance Support, Equipment Inventory are some of the Facilities and Utilities services we offer.

Our Mission

To provide quality service, value and growth to our clients by planning, implementation and support, effective and efficient business processes that assure sustainable compliance and regulatory standards.

COMPLIANCE PROJECTS

YEARS OF EXPERIENCE

%

Satisfaction

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I highly recommend the staff of Quality Consulting Group. They worked with me as an Independent Consultant in a Pharmaceutical client. They were a key resource in developing and providing the client with an assessment and Remediation Plan to response their Form FDA 483 observations. The QA knowledge and background that they have, were fundamental in the success of the project.

AMELIA GUTIERRE
FORMER SENIOR DIRECTOR BRIGHTON ASSOCIATES L.L.C.

I had the pleasure of working with personnel of the Quality Consulting Group. They have always demonstrated great diligence and integrity. Their expertise and that of those they selected for us was key in the expeditious resolution of various complex validation projects. During this time, QCG held several critical positions within the Quality Organization, being instrumental in leading the site in a number of major initiatives under a very demanding work schedule. QCG is well respected and influential at all levels. QCG was instrumental in the implementation of new standards and site procedures to meet FDA Consent Decree obligations. Ultimately, the site and the corporation were able to lift the consent decree in large part thanks to QCG. They have the ability to carry out innovative and very effective work practices. I highly recommend QCG to any prospective employer.

LIMAR VÁZQUEZ SOTOMAYOR
PRODUCT SOURCE MANAGEMENT LATIN AMERICA MERCK

ABOUT US

At Quality Consulting Group LLC, we plan, implement and support effective and efficient business processes that assure sustainable compliance with highly technical regulatory standards.

OUR ADDRESS

Ave. Alejandrinio C-5,
Guaynabo, P.R. 00971

support@wearequality.co

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