What we do?
Your Trusted Partner in Regulatory Success.
What we do?
Registration
- Prepare Required documents for registration new product ,Factories as well as keeping the renewal registration according to governmental sectors requirements.
- Regulatory strategy and consulting.
- Product registration and approvals.
- Regulatory submissions & documentation.
- Post-market surveillance & compliance. Labeling and advertising compliance.
Pre Inspection Factories
Pre auditing the factories preparing checking SMF according to WHO format companied official authorities auditing complete all foreign factories registration as per requirement of WHO .
Inspection checking list
Premises and department
1/ Personnel
Organization chart and List of technical staff.
2/ Factory utilities
Warehouses: (Raw material, finished product & Packing Material).
HVAC System: filters type according to zone classified. Water treatment system .
Maintenance : all maintenance type. Waste.
Products
- Pharmaceuticals
- Medical devices.
- In vitro diagnostics
- Biologics and biotechnology/(Vaccines & Hormones).
- Nutritional products
- Disinfectant
- Diagnostic kits.
Manufacturer
prepare site master file according to WHO format for all production lines.
- Oral solution site.
- Injection site.
- Powder for injection.
- Water soluble powder.
- Tablets & bolus site.
- Beta- lactam.
- Vaccines.
- Hormones.
- Disinfectants.
- Medical devices.
- Diagnostic kits.