Our Services

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MERAS Provides regulatory affairs advice at all stages before submission of a dossier for marketing authorization and during the registration process by coming up with the proper response to HAs questions.
With our extensive practical experience in regulatory affairs, our experts understand and can interpret regulatory scenarios for clients. We can provide help in seeking the opinion of regulators during the pre-submission phase of a project can prove to be vital; strategies for interacting with regulatory agencies contribute towards achieving consensus at pre-submission meetings.
If you need any regulatory advice related to the Middle East countries.


As the regulatory requirements in the Middle East region become increasingly complex, it is important to understand how best to approach the regulatory hurdles. Getting the regulatory strategy right is of the utmost importance in ensuring the best possible outcome bringing the medicine to market. It should be noted that each product is different, and has its own issues. MERAS provide strategic guidance to optimize your approach to achieve the best possible registration outcome by evaluating of the different regulatory procedures available and how they apply to your particular product. If you need help in designing your regulatory strategy in one of the Middle East countries.



A successful submission is the way to a successful marketing authorization. Dossier compilation for submission in the Middle East region is by no means a routine task. It requires a good understanding of the product and the each Health authority’s process. MERAS services in this area include:

  • Compiling of an efficient and complete dossier including manufacturing site. (whenever manufacturing site registration is necessary).
  • Completion of country specific forms.
  • Preparation of price certificates.
  • Continuous assessment of the dossier and provide possible solutions.

If you are looking for a successful and efficient submission of your dossier at one of the Middle East authorities.


Review Process

Our experts provide their input on the interpretation of questions, understanding the additional documentation that will be required. The regulatory procedures in the Middle East differ significantly. And the respond to Health Authorities requirements and questions need a deep understanding of those procedures as well as Health authorities expectations which is one of the strengths that our experts have. Here, our expertise can be invaluable. If you need our support during the review process of your dossier

Documentation and Archiving

One of the success factors of the regulatory function in any company is the proper documentation and archiving system is an important tool and essential need. MERAS provide you with Regulatory Databases and archiving systems that fulfill your need and facilitates retrieving your regulatory documentation and data. We can also keep your archiving and database system continuously updated and maintained. Regulatory database need to include copies of dossiers, official approvals, registration status, labeling, official communication with Health Authorities as well as all procedures and guidelines that applies to your products. If you seek an efficient database system and regulatory archive that suit your business and regulatory needs

Health Authority

The key to any successful regulatory strategy in the Middle East region is a fruitful interaction with the relevant Health Authority. Again this is were our experts have an edge with their long experience and reliable interaction with the different Health Authorities in the Middle East countries that lasted for over 20 years. It is of the utmost importance to understand how to approach, who to contact for each specific issue and how to receive Health Authority response and to properly interpret and interact. MERAS is experienced in preparing for, and assisting clients at Health Authority meetings and interaction. If you would like help with your approach to the regulatory agencies, or would like further information

Market Access and Pricing Strategy

MERAS provides professional market access and pricing consultancy services that combine strong technical know-how with real strategic expertise. We offer our customers professional solutions to their Pricing & Market Access, named patient access and tender related issues. We build innovative tools that analyze real options and present analysis frameworks that enable our customers to take enlightened decisions about their company strategy. If you want to overcome and to anticipate pricing and market access issues that will arise while starting your business in the Middle East

Regulatory Intelligence

MERAS provides an information service that allows you to stay up-to-date with the dynamic and challenging regulatory environment in the Middle East region and helps you to understand the significance of key regulatory documents and their potential impact on your product portfolio. If you need information and interpretation of current or merging regulatory requirements or Regulatory news in the Middle East

Labeling and Artwork

One of the major requirements to obtain the marketing authorization in the Middle East is the submission and implementation and continuous update of the Arabic containing labeling (mainly the package insert). This should be based on the current existing label in the country of origin (or reference country). This has been a big challenge for many international companies especially with the unique characteristics of the Arabic language. MERAS experts excel in this area. If you want to have English/Arabic labeling that complies with the requirements in the Middle East countries


MERAS is also willing to establish a long term partnership providing integrated and long term regulatory service including all the above mentioned services into one package to our clients. If you are looking for a full integrated regulatory service in the Middle East

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