Egypt’s burgeoning demand for medicinal products due to demographic growth and urbanization makes it one of the top markets in Middle East and Africa. All drug products are required to be approved by the Egyptian Drug Authority before distribution or marketing in the country. From decoding the Regulatory framework to aligning with the Regulatory requirements, being compliant with Egyptian Drug Authority might be a tedious task for new market entrants. Added to that, eCTD conversions, Active Pharmaceutical Ingredient designs and other Regulatory processes might require a special attention in order to adhere to the stringent regulations.
Freyr offers Regulatory assistance in both understanding the regulations and aligning with them in a streamlined manner with a focused strategy for compliance. With Freyr’s experts ensuring cost-effective and time critical approaches for all processes, applicants are assured quick turnaround times to address the compliance requirements.
- Regulatory submission roadmap for medicinal products registration in Egypt
- Regulatory consultation during the development of the medicinal products
- Pre-submission administrative activities, pre-submission interactions with health authority (HA)
- Regulatory assessment of source data
- Compilation and submission of the dossiers to HA in CTD format
- Assistance for strategy, compilation and submission of post-approval changes
- CTD conversion of legacy products from old/paper format
- Designing of specifications for API, finished product & intermediates
- Limits for impurities including genotoxic & elemental
- Protocol design for bio-equivalence, stability, analytical method validation, exhibit batch, process validation
- Change control evaluation and compliance activities
- Support for HA query response for pre and post-registration
- Product re-registration (renewal) for continuous market supply