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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.