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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

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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).

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 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).

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Regulatory Affairs
Planning Solutions

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

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.
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We’re here to bring solutions and be the strategic facilitator of choice for business and operations leaders in the pursue of excellence in their processes. Let’s work together and Evolve your organization towards an improved operation.

Schedule an Appointment

Call us at (787) 339-2460 or complete the following form.