Pharmaceutical Manufacturers

Naratech Consultancy Services to Pharmaceutical Manufacturers

Naratech pharmaceutical consultancy provides pharmaceutical manufacturers with the following consultancy services: 
 Quality System Establishment/ Upgrading According to 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)

 Validation/ Qualification:

Qualification protocols preparation & execution for utilities, instruments &equipment in drug manufacturing facilities & drug stores. 

Validation protocols preparation & execution which include process validation, cleaning validation & analytical method validation. 
validation master plan preparation.

Calibration/preventive maintenance protocols & 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 & follow up with regulatory authorities & principals.

Pre-Inspections for Facilities, Which Include Preparation of GAP Assessment Reports & Generation of Task Plan, to Assist the Companies to Get GXP Approvals.

Complete System Establishment (With SOPs & Flowcharts Generation) Which Comply to 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
    • Setting Specifications Procedures
    • Approval & Evaluation Procedures 

Facilities &Labs Design for Regular & Cytotoxic Product Manufacturing According to Current GMP Standards & for All Pharmaceutical Dosage Forms

Total Staff Recruitment Solution, Sourcing & Screening Process

Training on All Technical Issues Related to Pharmaceutical Product Manufacturing, Testing & Compliance

 Organogram Establishment for the Company Structure

 Job Description Preparation

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