Regulatory Affairs Solutions
Quality Systems Compliance
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ECONS has resources with the expertise to oversee your company compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.
ECONS divides Regulatory Affairs support into four (4) main areas:
- Process & Project Consulting
- Program Management
- Planning Solutions
- Execution & Submission Solutions
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Regulatory Affairs Consultants
ECONS has consultants that will help you identify best practices and ultimate tools to define the company regulatory affairs process and technologies for you company programs (New Product Introduction/ Acquisitions/ Divestitures/ Massive Changes in Company Products/ Manufacturing Site Change).
ECONS has proven experience in assessing & identifying gaps in companies’ Regulatory Affairs performance and culture.
- Development of new processes and procedures
- Generate the new metrics and key performance indicators
- Design and give training
- Define project scheduling
- Generate quality and auditing processes
- Define the new governance
- Ensure process adaptability to company culture
All this will be around a continuous improvement environment that will be embedded in all the defined strategies.
Regulatory Affairs
Program Managers
ECONS will provide resources to oversee the Regulatory Affairs program introduction providing Regulatory intelligence to create strategies for Health Authority (HA) submissions in regions (LATAM/ ASPAC/ EMEAC) to obtain success in market approvals (schedule/ cost/ scope).
Regulatory Affairs
Planning Solutions
ECONS has resources that will help companies in the Regulatory Affairs assessment of changes, new product introduction, renewals, and others. Also, we will help in the overall planning process
- Planning for regional or global projects
- Identify interdependencies and new strategies between product or projects
- Schedule, monitoring and tracking of all Regulatory Affairs project activities
Regulatory Affairs Execution & Submissions Solutions
ECONS will assists your organization to execute, monitor and control the entire Regulatory submissions management process, right from dossier development, submission scheduling, tracking of all activities, and final submissions to Health Authorities (HAs) including interaction with them.
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Naturally as a consulting and contracting business, we are where our customers need us, when they need us.
