MENA Region

Regulatory Affairs in the Middle East and North Africa

EMMA International Consulting provides expert consulting on regulatory affairs in the Middle East and North Africa, including quality and compliance, quality management systems, FDA regulations, biotechnology, medical devices, and clinical studies.

The Middle East and North Africa (MENA) is a region encompassing approximately 22 countries and accounting for approximately 10% of the world’s population with an average increase of 3.5% per year. Since the MENA owns around 60% of the world’s oil reserves and 45% of the world’s natural gas reserves, it became an important source of global economic stability.

In alignment with this growth, the MENA region is significantly expanding in terms of services, quality, infrastructure AND need. The healthcare industry is ranked # 3 after the “Oil and Gas” and “Banking and Finance” industries.

Based on that, the healthcare industry is moving faster and below are some facts about its status:

  • Size of healthcare expenditure is increasing by an average of 6% / year for the whole region
  • Local Medical Centers are affiliated (or accredited) with with EU / US centers
  • Regulatory authorities recently started by designing strict requirements and regulations for monitoring of the industry which requires more international expertise and consultancy
  • Local pharmaceutical facilities started to work under Joint Venture Agreements with International Pharmaceutical companies
  • International and Local Clinical R&D is highly growing due to volume of population, high prevalence of several diseases, market access strategies, etc.

What We Do

EMMA International is a well-known global leader in management consulting services initially established in the US with a global footprint and servicing a large number of clients within the healthcare industry.

Below is a non-exhaustive list of services that we provide regarding regulatory affairs in the Middle East and North Africa:

Quality Systems

  • Supplier Qualification, coaching and monitoring
  • Effective design controls for the R&D units
  • Independent manufacturing QA & QC Services
  • Customer complaints management
  • Internal audits programs design and implementation
  • Quality audits (ISO, GCP, GLP, GMP, GDP)
  • Validation programs design and implementation
  • Quality Management System Upgrade
  • Process Re-Engineering

ISO Systems

Our experts are at your service in order to secure tailored quality systems, full implementation and complete on the job training programs to your internal staff – we mainly provide programs to cover the below certifications:

  • ISO 9001 – Quality Management System
  • ISO 17025 – Testing & Calibration Laboratories
  • ISO 13585 – Medical Devices: QMS
  • ISO 14971 – Medical Devices: Risk Management Strategies
  • ISO 15189 – Medical Laboratories
  • ISO 14001 – Environmental Management
  • ISO 22000 – Food Safety Management
  • IATF 16949 – Automotive Industry Action Group
  • OHSAS 18001 – Occupational Health and Safety Assessment

FDA Compliance

With the continuous and strict requirements of the FDA, EMMA International reacted by developing tailored programs of consultancy to assist its clientele throughout the globe, such as:

  • Remediation Strategies
  • Mock FDA Inspections
  • Audit and Gap Analysis
  • Labeling & Website Reviews
  • Regulatory Submissions

Regulatory Affairs

In alignment with the strict regulations of the regulatory authorities, EMMA International will be able to partner with your institution on mainly the below services:

  • Prepare submissions for CE certification and product CE marking
  • Design Dossiers and Technical Files (CE Mark)
  • Prepare submissions and assist in international registrations
  • Audit your Clinical Projects from start-up until closing
  • Management of Recall Projects

Our Targeted Clientele

Life Science and Healthcare industry is the core business and identity of EMMA International and we are always trying to assist all type of organizations through their journey; below is a non-exhaustive list of targeted clienteles:

  • Medical Centers / Research Centers
  • Pharmaceutical / Biotechnology and Medical Devices Companies
  • Regulatory Agencies
  • Medical Laboratories and Warehouses

Why EMMA International in the MENA

With the growth in the consultancy concept around the globe, EMMA International has distinguished itself by creating a unique approach for consultancy.

  • Fully tailored services based on client need and regulatory requirements
  • International expertise with large number of subject matters
  • Local Resources in the MENA with International expertise and endorsement
  • Cost-effective programs securing high rate of success and sustainability of outcomes
Ready to learn more?