• info@alwajerpharma.com
  • +968 7953 6773, +968 9935 4545

Regulatory Compliance

Our regulatory department works on the guidelines of CTD and ICH. Our team is engaged in day-to-day Preparation of dossiers - DMFs, interacting with all the key personnel to keep updating them for regular regulatory developments and features in the international arena. Teams also upgrade day to day operations of the plant, making sure that everything works in sync with the regulatory requirements.
Our RA Team is constantly and continuously engaged in product registrations in various markets (emerging and regulated) across continents. The core responsibility of our RA Team is to register products in the international and markets, in order to gain access for such products in shortest possible time.

Research and Development

Research and Development is the backbone of Al Wajer Pharmaceuticals with distinctive and unique combination of the depth and breadth of capabilities, coupled with world-class infrastructure, sustainable partnerships and a robust product portfolio.
R&D provides a nurturing environment to a multi-disciplinary team of dedicated scientists striving for excellence. R&D is well equipped with various modern PLC based Equipment and technologies required for conducting high quality research activities.
Research and Development brings together a team of enthusiastic scientists and technologists employed at our state-of-the art facility with focus on innovation led pharmaceutical powerhouse providing affordable healthcare solutions with uncompromising quality. The scientists work closely with the respective business development teams to generate innovative concepts and ideas, exploiting both the unmet market and synergies across therapeutic areas.

Quality

AL Wajer aims at achieving excellence in quality and customer satisfaction through Good Manufacturing Practices and strives for continual improvement. We have fully equipped quality control cells equipped with Wet Lab, Instrumentation Lab and Microbiology Lab to carry out intermediate, in-process and final product analysis.
The instrumentation includes HPLC's, GC with Headspace, UV Spectrophotometers, FTIR, TOC Analyzer, Polarimeter, Mili-Q-Water System, Dissolution Apparatus (Manual & Auto) walk in Stability Chambers for all climatic zones, BOD Incubators, LAFU, Biosafety Cabinet, HPHV Autoclave etc.
We have the required infrastructure to ensure full operation of the quality function from Raw material analysis to in process analysis and analysis of final products.
The Manufacturing Equipment includes FBC’s with 600 kg, 750 kg and 350 kg capacity, homogenizers, Tray driers, sifters, pulverizes, coating pan, Extruder, spheroniser etc.,

Health, Safety and Environment

Al Wajer Pharmaceuticals is committed to conservation of environment, health and safety of its employees. The company’s growth plans are in line with environment, health and safety policy. Awareness programs and training to all the staff and workers on safety and environment is a continuous activity. Continual improvement is the key factor in achieving highest standards of sustainable growth.

Our Environmental Management efforts are:

  • Installation of air emission control equipment for controlling particle and air quality.
  • Development of "Green Belt" on the perimeter of the entire facility.
  • Conservation of natural resources: minerals, water and energy to maximum levels.
  • Operations are engineered in a closed loop system where all water is treated and reused to achieve zero discharge.
  • Compliance with all Local Legislations and Standards.

Our health and safety practices are:

  • Deployment of appropriate and adequate Safety Appliances.
  • Mandatory use of personal protective equipment.
  • Provision of safe drinking water.

Certifications and Approvals

  • GMP (Good Manufacturing Practice) Certificate by the Ministry of Health, Sultanate of Oman
  • ISO 9001:2015 CERTIFICATION