FAQ | ECI | Enhanced Compliance Inc.

FAQs

Why do companies need consulting services?

Consulting services can be a cost-effective way to address an immediate need within an organization. Consultants enter your organization fully trained in the area of need and can support developing the same skills within your own team or simply free up your team to work on other business priorities. Consultants can be used to bridge a resource deficit while your internal talent acquisition team searches for the ideal candidate to fill the void. Consultants provide a unique perspective to challenges as they have experienced similar issues at other organizations and clients. Finally, consultants are available for all lengths of engagements, giving you flexibility to scale up and down as budgets allow.
ECI provides consultants in many subject areas but, as a project management office (PMO) based organization, offers individualized management of all your resource and project needs as well.

What types of services do you offer?

ECI provides consulting services in regulatory, quality and engineering specialties.
ECI's Regulatory Affairs staff actively monitor and analyze publicly available resources to stay up to date on current regulatory requirements. Current regulatory intelligence helps to provide sound rationale for the applicable requirements for a specific project. Consults define the scope of regulatory oversight to ensure all applicable entities are defined (i.e., FDA, ONC, SEC, state law, Competent Authorities etc.) to ensure compliance.
ECI provides an assessment of its clients Quality Management System for conformance to requirements to identify potential areas of improvement. Depending on a client's need, ECI can establish and implement a new Quality Management System or provide targeted recommendations to address a specific area of non-conformance.
Consultants conduct mock audits to mirror a regulatory agencies sampling of company records used to support product safety and effectiveness. A mock audit can help determine preparedness for inspection and identify areas for training.

There are several ways a consultant supports the monitoring of a devices' performance in the market to ensure product safety, efficacy, and compliance. Consultants can provide quick access to timely data surrounding the industry’s total product lifecycle of a particular device. This will help a manufacturer recognize market signals when reviewing their own technology and complaint handling records. Consultants can ensure the clients Quality Management System is robust, that its procedures contain required elements to effectively address Complaint Handling and Medical Device Reporting as well as feedback into the required activities for risk management, clinical evaluation, and post-market review processes. When applicable, ECI can augment existing staff resources to ensure timely complaint handling and medical device reporting per the regulation.

‍ECI provides training programs tailored to meet the specific needs of its client. Examples of typical training programs include:
- Complaint handling
- Medical device reporting
- Implementing effective Corrective and Preventive Action
- Implementing an effective recall program
- Preparing for agency inspection
- Other Quality Management System elements
Enhanced Compliance is not a staffing organization.
How does ECI help a company obtain market access?
Our regulatory team can define an appropriate regulatory strategy using the applicable regulations and guidance’s based on the client’s strategic business requirements and timeline. The ECI team can provide an assessment of the company’s Quality Management System and its conformance to design controls to ensure an efficient regulatory submission process. Consultants prepare the client to interact with regulatory agencies at the appropriate time, to obtain feedback prior to the submission of a marketing application. Our services include writing, assembling, reviewing or support to submission preparation, responding to agency requests for information throughout the review process to obtain 510(k) clearance, PMA (Premarket Approval) or a license is granted.

How experienced are your consultants?

Enhanced Compliance Inc. (ECI) is a dedicated team of industry professionals and program managers with a proven history of success in compliance programs for pharmaceutical, biotech, medical device, and related industries. Our consultants have an average of 15 years of experience working in the life sciences industry.
In addition to our experienced management team and highly skilled staff, we have developed an extensive network of global consultants and subject-matter experts allowing us to provide quality, regulatory, program management and engineering solutions for bringing a wide variety of medical and health-related products to market. Engagement with ECI provides access to a larger network of consultants, some with previous regulatory agency experience including the US (United States) Food and Drug Administration.

How do you stay up to date on the latest industry regulations and trends?

ECI's Regulatory Affairs staff actively monitors, gathers, and analyzes publicly available regulatory resources to be communicated across the rest of the company via our internal Regulatory Intelligence site. This resource is provided to support the company's core value, Expert Knowledge. Our staff remains current on all regulatory guidance, and we have the experience to do the job correctly the first time and on time. The Regulatory Intelligence site is just one method ECI provides to ensure the consultant's commitment to continuous learning and staying abreast of evolving regulations, technologies, and industry best practices. ECI team members share their lessons learned and best practices via a monthly collaboration forum as well.

What is the typical duration of a consulting engagement?

Providing an estimate of how long a consulting project might take, depends on the scope and complexity.
We can engage with small and large organizations, startups to the fortune 500 and anything in-between, no minimum size for a project engagement. By actively collaborating with a client, ECI will come to understand the specific needs for a project in order to propose a comprehensive solution and timeline which may vary from a few months to a year.

How do you tailor services to each client’s unique needs?

Our team works collaboratively with its clients to understand the company’s environment, its people and staffing needs and the state of its Quality Management System, on site visits, video conferencing and document assessment provide evidence to help identify discrete actions to implement a customized solution.

What is your track record in successfully assisting clients?

We have a 97% retention rate with our clients.

How do you handle confidentiality and intellectual property protection?

ECI takes the protection of your information very seriously. Confidentiality and protection of intellectual property is discussed in both our Non-Disclosure Agreements and/or MasterServices Agreements with your organization. Our electronic systems are subject to multi-factor authorization to ensure the highest levels of security protection.

How do we initiate a consulting engagement with your firm?

Please contact infoNA@eci-rx.com to get started. We will assign the right resource to assist you in scoping your project and determining what is needed to get to a successful outcome.

Why choose ECI, and what differentiates ECI from its competitors?

Why clients choose to work with ECI
- We are a program-management based consulting organization and experienced in providing turn-key project support from assessment through execution, under the guidance of our program management office. Our consultants work collaboratively with clients to meet the strict federal and global requirements that govern the industry.
- Extensive experience from FDA employees.
- ECI understands the unique challenges and can formulate comprehensive strategic solutions.
- We maintain a deep and extensive understanding of compliance standards as they relate specifically to your market.
- We work effectively with critical project timelines to ensure safe products at all stages of the product lifecycle, from research and development through end-of-life.
Why consultants choose to work for ECI
- ECI Offers
- - Competitive salary
  - Performance-based bonuses
  - Excellent medical, dental, and vision insurance
  - Healthcare flexible spending account
  - Life insurance
  - 401k with company matching
  - Generous PTO program
  - Flexible work schedules
  - Employee assistance program for mental health
  - Learning and development programs

Questions Answered

FAQs

Have More Questions?