Manufacturing and Supply Chain

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:

Manufacturing and Supply Chain strategy

Preparation of global strategy for manufacturing and supply chain that is aligned with key stakeholders

Project management

Act as project manager for various projects according to customer needs

Interim management

Act as interim manager for Manufacturing and Supply Chain functions

Process simplification

Combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation

Process transfer to CMOs

Process transfer (outsourcing) to CMOs including management of these

Qualification and validation

Qualification of equipment and validation (process, analytical methods, and IT systems)

Regulatory documents

Writing of regulatory documents within Manufacturing and Supply Chain

Due diligence

Evaluation of target company’s manufacturing strategy including review of key documentation to assist investor in decision making

Manufacturing and Supply Chain