EXPERIENCED LEADERSHIP, RAPID RESPONSE, AND EXACTLY MATCHED TALENT

Quality Assurance & Control

In both the U.S. and Europe, life sciences companies are reporting sharp upticks in warning letters from regulators. Whether you’re looking to manage specific responses or remediations, develop a Quality 4.0 transformation, or otherwise fill gaps in skillsets and experience, The Evanston Group can help. We have a proven track record of helping companies like yours find the right people with the right skillsets and experience to tackle even the toughest quality assurance and control challenges.

PROJECT MANAGERS AND SUBJECT MATTER EXPERTS FOR QUALITY ASSURANCE & CONTROL SUPPORT

Success requires the right people with the right skillsets – and those people are increasingly hard to come by. That’s where The Evanston Group can help.

Our consultants have thousands of hours of quality assurance and control expertise. We’ve helped clients respond to regulatory citations, remediate issues raised in 483 warning letters, and design and manage Corrective and Preventative Action (CAPA) workstreams. We’ve also helped clients post-acquisition harmonize the quality management systems and bring newly acquired product lines into compliance. With a combination of this experience, rapid response, and exactly matched talent, we get you the right people with the right skillsets to fill your gaps.

DELIVERING VALUE ACROSS A WIDE RANGE OF QUALITY ENGAGEMENTS

483 Responses

Warning Letter and Consent Decree Prevention & Remediation

Remediation
Design History Files, Device Master Records, Drug Master Files, Risk Management, CAPA and Adverse Events (AE) Document Control

Complaint Systems Development & Management

Quality Systems Development & Management

Supplier Quality Assessments, Relationship Management & Remediation

GxP Consulting
Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP)

Quality & Reliability Engineers

Third-Party Experts

REMEDIATING ISSUES IN FDA CONSENT DECREE AND SAVING GLOBAL DEVICE FIRM $200 MILLION

When you’re out of compliance and your bottom line is suffering, rely on our experts to get you back on track ASAP.

This multi-billion dollar device company was struggling under an FDA consent decree that prohibited the sale of its devices and the development of upgraded products. The Evanston Group provided a team of experienced project managers and SMEs. Within five months, the team had closed 1,906 compliance gaps in the supplier management database and 159 supplier audits, and implemented new corporate supplier procedures.  

The remediation plan and subsequent FDA clearance allowed the company to get back to business in a timely manner, which saved an estimated $200 million in product recalls and other expenses. The plan also yielded a pathway for the company to resume its efforts to introduce new products to the marketplace.

SUPPORTING CAPA AND DHF WORKSTREAMS FOR 483 WARNING LETTER REMEDIATION

Our project managers and subject matters experts have deep experience helping life sciences leaders remediate the issues raised in 483 warning letters.

This Fortune 500 medical device firm was in the process of developing a consolidated master plan for global remediation due to 483 warning letters. The Evanston Group delivered two quality teams, including project managers as well as subject matter experts, to support the firm’s Corrective and Preventative Action (CAPA) and Design History Files (DHF) workstreams. We helped the client remediate the issues and get into compliance with the current regulatory standards – so they could continue selling their products.

BRINGING ACQUIRED PRODUCT LINE UP TO CURRENT REGULATORY STANDARDS

We have project managers, but also subject matter experts – like this design engineer and systems engineer.

When this leading life sciences firm acquired a new company, they turned to The Evanston Group to help proactively get the new product line’s quality documents up to current FDA standards. We brought in a design engineer, a systems engineer, and a project manager to help bring the product line up to current regulatory standards.

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what our customers say

“Knowing how to match consultants with the industry knowledge who can jump right in, hit the ground running, and make it work for clients is why The Evanston Group is a top-notch organization from top to bottom.”
- Senior Project Manager and Clinical Researcher
“Placing hard to find, adaptable people with very specialized backgrounds and a working knowledge of projects that are more complex to run is how The Evanston Group differentiates from others in the market.”
- Clinical Manager specializing in rare disease
“My expectations were exceeded by the caliber of people The Evanston Group brings in. When I am looking for a special mix of talents, skills and background, The Evanston Group has been able to find and screen a very high quality set of resources. They are immediately right on target.”
- Senior Vice President, $10B medical devices company
“It is rare when a company and its associates can exemplify so many wonderful values with forethought and respect for those in their employ.”
- Software Engineer Consultant, Johnson & Johnson

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