Regulatory Affairs Solutions
Quality Systems Compliance
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 support into four (4) main areas:
- Process & Project Consulting
- Program Management
- Planning Solutions
- Execution & Submission Solutions
Schedule An Appointment
Call us at (787) 339-2460 or complete the following form.
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).
- 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
ECONS will provide resources to oversee the RA 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).
ECONS has resources that will help companies in the RA 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