Bio Egypt Services

Better Technology For Better Healthcare

Bioegypt is dedicated to helping you get the most out of your research and production. For years, we have provided unmatched personalized application and engineering expertise to companies around the world.

Our broad investment in people with a deep understanding of drug development, coupled with state-of-the-art facilities and equipment, allows BIOEGYPT to provide end-to-end API services from process R&D, to API manufacturing at phase I, II, III and commercial scale.

BIOEGYPT development services also include pre-formulation studies, analytical development, stability evaluation and formulation development, all the way to CMC services.

All of these services are integrated to help our clients quickly and seamlessly move NCEs from preclinical stage to patients.
Our team of experienced scientists and engineers understands the complexity of your work and are here to support you every step of the way.

BIoEgypt Service

Is an industry proven standard of industry use, for managing controlled environments.

Nova-EM is a process based solution that maps to your entire sampling workflow. The software controls the process as a whole, not just scheduling for individual sampling points, but also capturing all critical quality control parameters. By enforcing compliance with standard operating procedures Nova-EM facilitates cGMP and following best practices. This includes the integration of the QC Laboratory, instrumentation and mobile sample acquisition in a paperless environment.   

 

Nova-EM Key Benefits:

•Improved operational efficiency saving time & money

• Powerful risk management tool for establishing & monitoring a risk based Environmental Monitoring programs

• Risk mitigation through Smart Monitoring

• Identify contamination sooner

• Reduced regulatory & business risks

• Enforced GMP & Best Practice minimizing critical operator error

• Processed-Based Feedback Ensures “State of Control”

• Real time data trending & analysis

• Alert and action level excursion management

Ensure that all equipment is operating at peak efficiency with the Preventive Maintenance and Calibration (PMC) module .The module provides tools to track spare parts inventory, equipment in repair, reorder of parts, results of tests passed and failed, and other KPIs .

Consumable Inventory Management Software (CIMS) is a comprehensive inventory management software system that is able to effectively track the physical location of any type of compound and interface with analytical balances. Internal or external orders can be tracked and authorized users are able to check-out compounds to fill the orders.

This system is language-independent and capable of detecting the smallest error on printed materials, including not only discrepancies between characters but differences between pictures and colors as well. The Automated Proof Reader replaces the tedious task of manually verifying printed material in different languages, saving your organization both time and money.
Nova-EM Key Benefits:

  •  Automatic batch verification against master document
  • Language independent & capable of detecting smallest errors
  • Capable of analyzing predefined number of samples
  • Eliminates manual verification
  • Automatic e-mail notification
  •  Increased efficiency & productivity -Guaranteed accuracy

Stability Management Program is a powerful feature-rich system that facilitates start to end management of all types of Stability Studies, from study design to sample storage, to analytical testing, approval phases and most importantly statistical analysis, shelf life determination and reporting ..

is an integrated module that will assist companies manage their incoming raw materials, in-process materials, and finish goods from registration of the material to final disposition. Material registration is either through the application itself or via interface with ERP systems such as SAP.  Some ERP systems have basic material management testing as part of their offerings .

GMP requirements (2l CFR parts 210 and 211), ISO standards, and industry best practices require pharmaceutical and biotechnology manufacturers, contract research organizations, and lab services organizations to implement reliable quality management systems. FDA’s Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations calls for a “comprehensive quality systems (QS) model” which integrates various aspects of the quality, manufacturing, and risk management using a holistic approach.

1- Providing the required prequalification document and experts CV

2-Providing well proven technology, previously applied and the reference list

3-Pre-contracting technical discussion and life presentation

4-Eu GMP compliant conceptual and basic design including the Room Data Sheet

5-Process flow diagram and control points

6-Detailed equipment and utilities technical specifications meeting Eu-GMP

7-Validated production SOP and validated testing procedures supported by validation protocols/reports

8-Detailed technical specifications for raw materials and packaging materials

9-Stability testing procedures and protocols/reports

10-We may provide the biological strains depending on their availability and its compliance with local regulatory body, required for manufacturing in case of technology transfer for a biological production. The strains should be supported by full documentation and strains bank maintenance .

11-Experts to attend the trial batches and to provide training for client personnel

12-Providing the project design qualification protocol/report

13-Reviewing equipment/systems installation and operational qualification (IQ, OQ) protocols

14-Witnessing the execution of IQ and OQ protocols

15-Developing the equipment/system performance qualification protocols

16-Witnessing the execution of PQ protocols

17-Developing and witnessing the process validation protocol including the cleaning validation