Manufacturing of medicines and medical devices is quite different compared to conventional manufacturing. Often these products are lifesaving and patients rely on the products being both efficacious, safe and of high quality. As a result, the industry is highly regulated. To be successful and competitive you must establish a lean manufacturing process that is compliant with the rules for Good Manufacturing Practice (GMP). Balancing lean principles and GMP is not trivial. Furthermore, as a manufacture you need to be in control of the whole supply chain from sourcing of raw materials and components to shipment of products to clinical sites or wholesalers.
Spot-on Pharma Consulting can help you within below areas:
Preparation of global strategy for manufacturing and supply chain that is aligned with key stakeholders
Act as project manager for various projects according to customer needs
Act as interim manager for Manufacturing and Supply Chain functions
Combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation
Process transfer (outsourcing) to CMOs including management of these
Qualification of equipment and validation (process, analytical methods, and IT systems)
Writing of regulatory documents within Manufacturing and Supply Chain
Evaluation of target company’s manufacturing strategy including review of key documentation to assist investor in decision making
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