Pharmaceutical Manufacturers

Naratech consulting Services to pharmaceutical Manufacturers

Naratech offers the following consulting services to pharmaceutical manufacturers:

I. Quality system establishment and improvement in accordance with current FDA and EU GXP regulations, which include:

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  • Good Documentation Practices (GDP)
  • Current Good Manufacturing Practices (cGMP)
  • Good Laboratory Practices (GLP)
  • Good pharmacovigilance practices (GVP)

 

II. Validation/ Qualification:

  • Preparation and implementation of qualification protocols for utilities, instruments, and equipment in drug manufacturing facilities and drug warehouses.
  • Preparation and execution of validation protocols, including process validation, cleaning validation, and analytical method validation.
  • Creation of site master file and validation master plans.
  • Creation of protocols and programs for calibration and/or preventive maintenance.

III. Regulatory Affairs issues: 

  • Preparation of registration files for the MENA region.
  • Preparation of registration files for EU and US markets.
  • Support on regulatory issues and follow-up with regulators and contracting authorities.

IV. Pre-inspections for facilities, including preparation of GAP assessment reports and a task plan to assist companies in obtaining GXP permits.

V. Complete system setup (including the development of SOPs and flowcharts) in accordance with current FDA/EU regulations for the following departments:

  • Quality Assurance
  • Production
  • Regulatory Affairs
  • Quality Control
  • Warehouses
  • Engineering 
  • Research and Development (R&D)
  • Compliance

VI. Establish and review the product development system for the development of products in CTD format for approval in the MENA, EU and US markets, including:

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

VII. Staff Recruitment and Training in all Technical Issues

VIII. Continuous Auditing Program

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