Naratech Pharmaceutical Consulting offers the following consulting services to pharmaceutical manufacturers:
Quality system establishment/improvement in accordance with current FDA/ EU GXP regulations, which include:
Regulatory Affairs issues:
Pre-inspections for facilities that include preparation of GAP assessment reports and task plan to assist companies in obtaining GXP permits
Complete system setup (with creation of SOPs and flowcharts) that meet current FDA/EU standards for the following departments:
Product development (R&D) system establishment / review for development of products in CTD format for registration in MENA, EU, & US market which include:
Design of facilities and laboratories for the manufacture of regular and cytotoxic products in accordance with current GMP standards, as well as all pharmaceutical dosage forms entire staff recruiting solution, sourcing and screening process training on all technical issues connected to pharmaceutical product manufacturing, testing and compliance organogram establishment for the company structure job description preparation.