ماجد فوزي

Updating Export regulatory affairs department in Pharaonia pharma, supporting QA, QC and production departments to update their internal SOPs/ procedures to be in compliance with international guidelines

Formulation and launching several tricky products
Establishing R&D laboratory

• Formulation development using various techniques.
• Analytical development (HPLC and UV)
• Package development.
• Supervision of scale up programs.
• Establishing the pharmacovigilance system.
• Establishing the department staff, cGMP's systems and procedures "SOP, specifications, logbook, .. etc".
• Participating in preparation of CTD.
• Participating in technical committee for purchasing plant equipment and instruments.
• Preparing products to bioequivalence study, reviewing study protocol, calculation of BE sample size, ..etc.
• Preparing PIL as per European guidelines.
• Good understanding of SFDA and GCC regulatory guidelines.
• Fair understanding of US-FDA and EMA regulatory guidelines.

Developing various formulations (solid, semisolids and liquids, sterile),
Key achievements:
Formulation and scale up of more than 50 products in various dosage forms