Spot-On Pharma Consulting

Spot-on Pharma Consulting helps pharma, biotech, and medtech companies with strategic advice and specific services within Product & Process Development, Manufacturing, and Quality by building on 25 years of industry experience and interaction with health authorities around the world. Your strategy for CMC and Device development of pharmaceutical drugs and medical devices can have large negative consequences for your clinical programs and marketed products if not done the right way. In early phases speed and proof of concept are in focus whereas process robustness and scalability become very important when you design for clinical phase and the market. Having an experienced partner that can guide you with phase appropriate development is key for your success. Manufacturing of pharmaceuticals and medical devices is quite different compared to conventional manufacturing. Often these products are lifesaving and patients rely on the products being efficacious, safe and of high quality. As a result, this industry is highly regulated. To be successful and competitive you must establish a lean manufacturing process that is in compliance with the rules for Good Manufacturing Practice (GMP). Balancing lean principles and GMP is not trivial. Furthermore, as a manufacturer 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 is your trusted partner utilizing 25 years of industry experience to guide you with development and manufacturing of pharmaceutical drugs and medical devices. Examples of tasks we can help with: Strategy, Interim Management, Project Management, Product and Process Development, Outsourcing to Contract Manufacturing Organisations, Due Diligence, Preparation of Regulatory Documents, Process Simplifications, Establishment of Quality Management System, Qualified Person (QP), Process Validation, GMP Inspections and Audits.