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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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