Validation Consultants South Africa
PharmOut validation consultants can work on projects on an hourly or fixed price basis. You can enjoy the practical validation strategies we've learnt in our work across multiple companies in the pharma and medical device industries.
Regulatory Changes
Our validation consultants keep abreast of the regulatory changes. We read the regulations and guidelines so that you won't have to.
Sensible validation
It's critical to know your process better before validation begins. It is no longer to acceptable to have reams of paper proving that your process is validated, whilst out on the plant you have a low RFT index! We can help you understand your process' critical factors and use that to drive your validation.
Our Validation Consultants offer:
Sound, practical approaches to your validation efforts. Our expertise will ensure that critical parameters that impact product quality are considered during this development process and allow you to register a design space*. This allows for optimisation and continuous improvement during the life cycle of the product.
*Design space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.
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Validation
GMP Compliance
Drug / Medical Device Registration
