FDA regulatory requirements for dietary supplements/nutritionals fall into a unique spectrum. Enhanced Compliance Inc. has experts in this complex arena available to consult with U.S. and foreign dietary supplement manufacturers in both bringing new products to market and in post-market reporting.
Our consultants can work with your team to develop compliant nutritionals manufacturing and reporting protocols, or we can review and improve upon existing systems. In addition, we can represent your interests in the case of non-compliance inspection findings to get your product-to-market timeline back on track.
- Quality Management Systems to Meet FDA CGMP (Current Good Manufacturing Practices)
- Electronic Record-Keeping Protocols Required for CFR Title 21 Part 11
- Risk-Management Auditing with Compliance Action Plan Development
- Guidance on Nutrition Labeling and Packaging
- Review and Creation of Compliant Marketing/Promotional Materials
- Import/Export Regulations Guidance
- Staff Training in FDA Regulatory Regulations
- Remediation Following Form 482: Notice of Inspection and Form 483: Inspection Report
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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, PMPProject 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. ShethVice 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. RagoneseSr. 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. HeffernanDirector 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.