A distinctly different consulting approach to advance your business interests.
Our consulting services include:
(A) Compliance Consulting - Quality Systems | Regulatory Audits | GMP Trainings
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle.
We design audit and corrective action plans to accommodate our client's needs, including MHRA, EMEA, and FDA regulations. During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company's various systems. We then recommend a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies.
We provide cGMP training programs to fit for client needs from cGMP orientation new hires through annual cGMP Training on various cGMP Modules. Our new hire cGMP orientation is an overview of basic GMP concepts and emphasizes, to new employees, the importance of understanding and following government regulations.
(B) Validation Consulting - Equipment Validation | Process Validation | Computer System Validation | Cleaning Validation | Analytical Method Validation
We possess extensive knowledge in various Pharmaceutical manufacturing processes, computerized automated control systems, laboratory instrumentation & information systems, and qualification, validation & audit programs. We have qualified staff to assist clients in assessing and defining their compliance and validation requirements for various manufacturing systems and provides the necessary resources to achieve these objectives.
(C) Commissioning and Qualification
We provide an efficient, effective documented program that follows and complies with global regulations and guidelines. Our engineering project life cycle experience ensures that commissioning and validation issues impacting on the design phase of a project are fully considered and integrated at the start of a project. We provide consistent guidance for design, construction, and commissioning and qualification of manufacturing facilities. Our qualification efforts will help with sound and responsible interpretation of regulations which govern manufacturing operations.