Mission Statement

To provide our clients with unsurpassed technical expertise in start-up, commissioning, validation, quality assurance, and regulatory consultation in order to successfully meet their needs in accordance with their schedule demands and budgetary requirements. 

Background

GL Consulting Company was formed in 1999 by Greg Lynch after leaving a career at a pharmaceutical company. As a consequence of his experiences as a corporate employee on several large-scale local and international projects, he formulated and refined an integrated approach to the management of Engineering-Procurement-Construction- Validation contracts. He recognized that the approach is widely applicable, but was rarely used on smaller projects or when multiple contractors are involved. To maintain flexibility and address the growing needs of clients, Engineering, Consulting and Validation Services, Inc. (ECVS) was formed in 2001. ECVS joined a cooperative partnership of several like minded companies to provide specialized, targeted capabilities to the pharmaceutical/biopharmaceutical/medical device industry.


Since the large consulting companies focused on the large projects while staffing contract validation personnel and the small companies desired only to supply manpower, no company was positioned to adapt the expertise and skills acquired on the large jobs to a wider array of validation projects. Engineering, Consulting and Validation Services was created with this objective in mind. As a testament to this new approach, ECVS partnered with a consortium of companies after September 11, 2001 in the successful rapid response to construct and validate a dedicated BL-2 facility to replenish the US smallpox vaccine supply.
 

Our Philosophy

ECVS has chosen its staff to reflect the requirements of an integrated engineering and validation program. The “core” group of project managers and senior consultants has experience in all aspects of engineering, validation, and quality systems. These “core” individuals have demonstrated the ability to execute the integrated philosophy and coordinate the activities of all disciplines to ensure a successful validation effort. Whether it is the execution of a single validation protocol, or multi-protocol execution from process development to the Pre-Approval Inspection, the development of a regulatory compliance action plan, or the ongoing validation of a production facility, the key to a successful project is the recognition by all disciplines of the importance of incorporating regulatory requirements into the project from the start.


ECVS partners also understand that the pharmaceutical industry is a worldwide business. Whether a company has international suppliers, operations, or customers, the engineering and validation group must be constantly aware of the vast array of international regulations and current Good Manufacturing Practices.

ECVS recognizes that only a service organization capable of providing consistent quality will survive in the aggressive consulting business. ECVS has based its hiring practices on finding those individuals who are motivated self-starters with proven skills in the industry.

Our Team

Greg Lynch - Project Manager : Senior Consultant

Beth Lynch - Validation Engineer & Project Leader

Bob Borghese - Sr. Quality and Compliance Advisor

Jose Amorin III - Quality Systems & Laboratory Validation Specialist

Kristy Adams - Laboratory Validation Scientist

Marty Amorin - Sr. Validation Specialist

Richard Kratzenberg - Sr. Electro-Mechanical Technologist

Michael Kaufer - Quality Assurance & Compliance Specialist

Ray Beery - Sr. Validation Specialist


Doug Smith - Sr. Validation Specialist


Leonard Sloan - Pharma Consultant


Our Partners

QVS, Inc.

AVST, Inc.

Water Dynamics Co.

CERTS, Inc.

MKCS Automation, Inc

Compliance Team, Inc.

CGMP Solutions, Inc.