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Approval and Commercialization

Our team ensures regulatory compliance and accelerates the process to provide a reliable market entry and commercialization path. We prepare the Common Technical Document for regulatory authorities.

Approval Process

We handle CTD preparation, compiling all necessary data into a Common Technical Document for regulatory submission. Our team ensures data submission to regulatory agencies, meeting all documentation and compliance requirements. We guide you through the food & drug approval process, ensuring your product meets safety and efficacy standards.
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Accelerating Commercialization

Our regulatory assessment services help identify potential challenges and streamline interactions with regulatory authorities. By managing regulatory submissions and approvals, we accelerate your path to commercialization and ensure compliance with international health and safety standards.

Let Us Support Your Product's Success

SartoMax is committed to accelerating the future of biopharmaceutical development. Contact us to explore more how our CDMO solutions can support your biomanufacturing goals.
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Frequently Asked Questions

The CTD is a standardized format for submitting data to regulatory agencies. It organizes product quality, safety, and efficacy information to facilitate review and approval across global regulatory bodies.
We manage the complete preparation of the CTD, ensuring that all technical, clinical, and manufacturing data are accurately compiled and formatted for submission to the UAE and international authorities.
Our regulatory team ensures your product complies with all local and international safety, quality, and efficacy standards. We assist in dossier submission, regulatory correspondence, and post-submission follow-up.
As a Dubai-based CDMO with international reach, we combine regulatory expertise, local market knowledge, and operational capacity to help biotech clients gain approval and successfully commercialize their products across the GCC and

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