Nextrans Solutions
QUOTATION
Limited
Quotation for the Implementation of a
Pharmaceutical Regulatory Information System
Quotation to Product Quotation
Burundi National Medicines Regulatory Authority (ABREMA)
DESCRIPTION Activities #Man DaysAMOUNT
Project Management and Advisory on the regulatory
Processes Project Mangement, training, changed management
Project Inception 15 $ 2,400.00
System Gap Analysis, requirement mapping and system design 20 $ 10,400.00
System Deployment, system security and infrastructural
15 $ 2,400.00
Support
Data Migration (In stances on unstructured data in an
30 $ 4,800.00
organization)
ICT Technical Training (On the Consultants Training Lab for
25 $ 13,000.00
the Change Management and Skillset Transfer)
Project Management & System development Tools $ -
System development and customisation: Development and Development and customisation of the supporting
0
customisation of the Regulatory Information system. system
Database management System: Support to the regulatory
20 $ 3,200.00
function dependancies and support to the business rules
Customisation and integration of the Document management
System for the document repository & version control, 15 $ 2,400.00
documents Requirement mapping & structure and access
Customisation, development and integration of the Self service
Portal for External stakeholders support in regard to profile
25 $ 4,000.00
management, applications submissions, tracking and registers
mamagement (All regulatory Functions)
Development and customisation of the System Mobile
35 $ 5,600.00
Application (IRIMS App) for Inspection and application tracking
Development and customisation of the Core
System development and customisation: Development and
Regulatory System that supports the organisation 0
customisation of the MIS
regulatory mandates
Marketing Authorization - Product Registration and Evaluation
50 $ 8,000.00
Module
Licensing & Inspection: Premises Inspection and Licensing 40 $ 6,400.00
GMP, Quality Audit Inspection & Inspections Module on Foreing
40 $ 6,400.00
and Locally Manufacturers
Import Export Control : Normal Products 40 $ 6,400.00
Import/export on controlled Drugs (Narcotic, Psychotropics
40 $ 6,400.00
and Precursors and others)
Clinical Trial & GCP 30 $ 4,800.00
Promotions and Advertisements Module 20 $ 3,200.00
Safe Disposal of Obsolete Pharmaceuticals Module 20 $ 3,200.00
Post Marketing Surveillance : on Planned surveillance based on
60 $ 9,600.00
implementation programs and routine
Pharmacovigilance ( 30 $ 4,800.00
Law Enforcement Module: 20 $ 3,200.00
Complaint Handling Module 20 $ 3,200.00
System Administration: User Management, workflow Concurren
$ -
management, system configuration and resources t
Product Recall management 20 $ 3,200.00
Finance Module : On the Billing and payment management Concurren $ -
Customisation and intergration of the Quality management
System forContol documents mangement, audits and
60 $ 9,600.00
inspections, workflow processes and other repository
management
Implementation and Integration of Laboratory Information development and customisation of the Laboratory
0
Management System Information Management System
DESCRIPTION Activities #Man DaysAMOUNT
Sample Management (Customer management, Sample
45 $ 7,200.00
Reception, Sample Inventory,Sample Tracking)
Sample Analysis (Field and lab Analyses. Results calculation,
submission, verification and publication ) Sample Analysis
60 $ 9,600.00
Scheduling Sample Analysis and Results Sample Results and
validation OOS Analysis Results Approval
Quality Control and Product Specifications 30 $ 4,800.00
Administrative and Financial Fees and Charges Management
(Billing. Management reports ) Integration to IRIMS Invoicing 20 $ 3,200.00
and Payment
System Administration User Management System Resource and
15 $ 2,400.00
configuration Workflow management System security
Quality managemetn system Controll Documents 45 $ 7,200.00
Reports and Analytics 20 $ 3,200.00
Machine and Intruments Integration 20 $ 3,200.00
Equipments & Consumables Inventory Management (Instruments
Interfaces. Maintenance and Calibration)
40 $ 6,400.00
Integration to RIMS System 15 $ 2,400.00
Integration to Payment Gateway for automated billing and
System Integrations 30 $ 4,800.00
Payment remittance on local and internation payments
Integration to Single Window 30 $ 4,800.00
Integration to the Core Finance system on receivables and
20 $ 3,200.00
Customer Accounts management
Post Implementation Support 1 year of free warranty and support 1 year $ -
TOTAL $ 189,000.00
If you have any questions concerning this quotation, please reach out to Nextrans Solutions Limited
Due upon receipt
info@nextranssolutions.co.ke
THANK YOU FOR YOUR BUSINESS!
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