Regulatory Affairs Department

Regulatory Affairs Department brief:


The regulatory department playing the role of organizing and harmonizing the communication between all the company departments and the Governmental Health Organizations and authorities in Egypt. The regulatory team works in a manner that build the road to the production, marketing, sales team, and export team, supporting the business cycle. The regulatory team supports the business process by the registration of new products in addition to re-registration of the products that has outdated registration license and also handle all the approvals that is requested by the other business departments on any updates related to the company products. The regulatory team assures the legality of each and every step in the business plan and supports the achievement of the company goals

Recent Change in Abilify PI:
6.2 POST-Marketing experience The following adverse reactions have been identified during post-approval use of ABILIFY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups, blood glucose fluctuation, oculogyric crisis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).  

 

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