Pharmaceutical Manufacturers

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:

• Good Documentation Practices (GDP)
• Current Good Manufacturing Practices (cGMP)
• Good Laboratory Practices (GLP)
• Good Validation Practices 
• Good Storage & Distribution Practices (GSDP)
• Good Cold Chain Management Practices (GCCMP)

• Qualification protocols preparation and execution for utilities, instruments and equipment in drug manufacturing facilities and drug stores
• Validation protocols preparation and execution, which include process validation, cleaning validation and analytical method validation
• Site master file and validation master plan preparation
• Calibration and/or preventive maintenance protocols and programs preparation

Regulatory Affairs issues: 

• Registration files preparation for MENA region
• Common technical document (CTD & eCTD) files preparation for GCC, EU, & US markets
• Regulatory issues assistance and follow up with regulatory authorities and principals

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:

• Quality Assurance
• Production
• Regulatory Affairs
• Quality Control
• Warehouses
• Engineering / Utilities
• Research & Development (R&D)
• Compliance
• Shipping & Distribution

Product development (R&D) system establishment / review for development of products in CTD format for registration in MENA, EU, & US market which include:

• Pre-Formulation Procedures
• Formulation Procedures
• Stability System Programs
• Analytical Methods Development & Validation Protocols
• Specification establishment Procedures
• Approval & Evaluation Procedures 

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.