The pharma industry compliance experts at Enhanced Compliance Inc. bring a wealth of knowledge and experience that can help to streamline the compliance process and circumvent roadblocks.
Companies that provide research, testing and manufacturing to bring new medicines to market face diverse challenges in our current economy. Strict federal regulations in the US and those set by global governments, though established to protect the population, require substantial efforts to prove efficacy and safety.
ECI-Rx can help.
From pharmaceutical compliance program management through validation testing, our consultants work closely with our clients to provide the services and resources needed to fulfill compliance requirements.
We are detail-oriented but our focus stays on the project goal. We work efficiently, following proven processes developed though years of experience. We work smarter, incorporating tested strategies and technologies to maximize effort and minimize risk.
We work for our clients.
Our corporate structure has inherent flexibilities, which allows us to offer clients a broad range of compliance consulting and services specifically targeted toward the pharmaceutical industry.
Entrust your reputation
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“High Quality Deliverables”
We contracted with ECI-Rx for a multi-year, multi-million-dollar remediation effort focused on updating existing commercially available products to meet state-of-the-art requirements per the Medical Device Directive.
Randy oversaw both project management (budgeting, resource planning and scheduling), as well as technical elements (specification development, test method/validation and risk management), managing day-to-day activities and strategizing with Senior Management.
I developed a strong appreciation for the ECI-Rx team’s skills and knew I could always count on them for high quality deliverables.
M. Adams, MBA, PMP
Project Manager, Endoscopy Sustaining Engineering, Boston Scientific Corporation“Responsive to our needs”
ECI-Rx has helped our company create key Quality System policies and procedures. The ECI-Rx management is very collaborative, engaging and responsive to our needs. They ensured that the work was managed effectively and efficiently.
V. Sheth
Vice President, Corporate Quality, Medtronic“Eager to do things right the first time”
I give my full endorsement to the key attributes that ECI-Rx will bring to your organization. Specifically, their knowledge, professionalism, drive, quality of work and eagerness to do things right the first time will add value to your impending project needs.
Brijesh and Shital were project leads on multiple devices ranging from urology to endoscopy; they remediated well over 1000 finished good codes combined over the course of 2 years. All work has passed multiple audits in the years since.
T. Ragonese
Sr. Process Development Engineer, Boston Scientific Corporation“Technical abilities are outstanding”
Randy, who served as project manager, is very skilled in all aspects of the quality system, with deep understanding of medical device requirements. His strong engineering skills and ability to mentor younger engineers was key to our overall success.
Brijesh and Shital both led specific elements under Randy’s leadership supporting our program. Their technical abilities are outstanding. Each of the 200+ projects within the program had upwards of 50 individual deliverables to meet the overall requirements. The team oscillated well between the multiple design elements, with the goal of meeting the final deliverable.
K. Heffernan
Director of Quality, Corporate Steward, Post Market Processes, Boston Scientific“Professional & Experienced”
Based on their experience, ECI-Rx recommended placing on-site managers to assist with activities and personnel which eased the added strain on our full-time managers due to the number of contracted resources.
I would not hesitate to use ECI-Rx for future projects; I found their professionalism and depth of resources was second to none. We succeeded in completing our mission and owe a great deal of the success to Enhanced Compliance.
J. Lane
Director, Endovascular Engineering and Product Development, Getinge Group, Maquet CardiovascularLearn how ECI-Rx can helpView our list of services