Regulatory Services
UAE is one of the fastest growing markets for pharmaceutical products in the region, with clear regulations and standard requirements to register any healthcare related product with the Ministry of Health.
Soranaus will closely collaborate with your team, and develop a tailor-made regulatory strategy for your product and guide you through every step of the regulatory process, ensuring pre-and-post submission follow up and timely registration deliveries.
Our regulatory experts will support you in:
- Regulatory Affairs consultation and strategy development.
- Knowledge of the regulatory requirements in different countries across the region.
- Dossier preparation (CTD & e-CTD).
- Dossier assessment and filing prior to submission.
- Submission of the registration dossier to the relevant authorities.
- Post submission follow-up to ensure timely approvals.