Our team members are highly qualified professionals having decades of experience in the pharmaceutical and healthcare fields and businesses. They have a real passion and capability to provide the required services in perfect and professional ways. Our methodology for delivering the training and services to the client is to assign the proper experts to complete the mission in an excellent way (make it right the first time is always clear to us).
Furthermore, our training team already worked with FDA, EU, JFDA, CAP, and ISO 15189 approved companies who witnessed many regulatory inspections in this regard. A CV for the trainers will be provided upon request.
Our team members are highly qualified professionals having decades of experience in the pharmaceutical and healthcare fields and businesses. They have a real passion and capability to provide the required services in perfect and professional ways. Our aim is to deliver remarkable training and services by selecting and assigning suitable experts to perform the training and to deliver the services in an excellent way.
Furthermore, our training and consultation team already worked with different Pharmaceutical and Healthcare companies that have approvals from the FDA, EU, JFDA, ISO, or (CAP which is related to the Healthcare). These certificates are given to companies after being witnessed by these regulatory inspections, which can be carried out with the help of our technical team upon request. Where the CVs of the trainers and consultants will be provided upon request.
Pharmaceutical Engineering & Qualification Experts:
Our team in this field who is specialized in Pharmaceutical Engineering and conducting Qualification and Validation (Q&V) for system and process processes is a skilled and dedicated team, and they have a solid and strong background in Pharmaceutical Engineering, Validation and Qualification (Q&V), and various aspects of quality that are applied in both pharmaceutical-related projects and operations.
Our team in this field has the ability to deal with and manage the different departments and fields in the various pharmaceutical industries in order to achieve the best coordination between quality, validation, and engineering aspects. Our team has professional experience in several different stages of the System’s and Equipment’s Lifecycle that covers design, procurement, validation, qualification, and calibration in the areas that cover sterile and non-sterile processes. In addition, our team has good experience in the facilities that produce API raw materials (sterile and non-sterile products ), and they have experience in dealing with the design and qualification of the following systems: production and packaging systems, Infrastructure, Clean Utilities, Computer Software Qualification (CSV) and the qualification of Analytical Instrumentation also.
Our team has a remarkable ability to achieve benchmarking performance by conducting an innovative Qualification and Validation (Q&V) by following a Qualification & Validation Risk-Based Approach.
Our team has more than 20 years of experience in various fields in the pharmaceutical industry of different dosage forms which include: Quality Compliance, Quality Control, Risk Assessment, and Risk Management, Compliance, Cleaning Validation, Process Validation, Technology Transfer, Analytical Research & Development, and Calibration.
Our team has proven through their long experience by recording record numbers of achievements such as obtaining the approvals of Local, European, and American regulatory authorities for manufacturing processes and obtaining cGMP certification, in addition to establishing and implementing risk management and evaluation systems for the various pharmaceutical manufacturing processes.
Medical Devices/ISO and Regulatory Affairs Experts:
Our team in this field has high professionalism to link the theoretical aspect with the practical one, and they have obtained high degrees in pharmacy and licensing (Registrations and submission procedures) from American and European universities that are specialized in pharmaceutical industries and facilities registrations, and they are specialized in establishing and developing ISO systems that are relevant t pharmaceutical and healthcare aspects, and they are considered as certified ISO Auditors. In addition, they are consultants and trainers for ISO 13485 of medical devices as they have distinguished experience in the management of “Regulatory Affairs of Drugs and Medical Devices “, in addition to their long experience in the requirements of the cosmetics industry and their experience In requirements for Pharmacovigilance.
Pharmaceutical R&D and Statistical Analysis experts:
Our pharmaceutical R&D team has over 25 years of experience in both the branded and generic pharmaceutical industries. The experience of this team covers all stages of pharmaceutical research and development (CMC), Process Developments, Process Scale-up, Process Optimization, and Process Validation. Our team has worked on implementing many successful projects that include drug development, dealing with novel chemical compounds, and checking their molecular structure. Our team offers specialized training programs in Quality by Design, basic statistics for non-statisticians, Statistical Design of Experiment, Statistical Process Control, and Technical courses for Manufacturing & Troubleshooting for operators.
Our healthcare team has more than 25 years of comprehensive experience in Total Quality Management, Compliance, Safety, Diagnostic General, Diagnostic Molecular Genetics, and Research Molecular Genetics Laboratories. Their experience covers the management and workflow of pre-analytical, analytical, and post-analytical processes, Test Method Validation, Instrumental Validation, Experimental Design, Experimental Troubleshooting, Bioinformatics Analysis, Tissue Culturing, Stem Cell Isolation, Management Of Reagent Storage System and CAP Certification (Certificate of American Pathologist (CAP) Accreditation Compliance Management & Inspection).