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Development of the medicinal product, the medical device or/and the combination product is an essential discipline that can have large consequences for your clinical programs or/and marketed products if not done the right way. In the early phases speed and proof of concept are in focus whereas process robustness and scalability become very important when you design for clinical phase III and the market. Having an experienced partner that can guide you with phase appropriate development is key for your success.
Spot-on Pharma Consulting can help you within below areas
Target Product Profile, Quality Target Product Profile, Critical Quality Attributes, Control Strategy, Critical Material Attributes, Critical Process Parameters, Critical In-process Controls, Specifications, Master Formulas and Tech Transfer
Design and Development Planning, Design Input, Design Output, Design Verification, Process Validation, Design Validation and Design Transfer
Requirements for drug and device combined into a streamlined process
Preparation of global CMC and Device strategy that is aligned with Clinical Development, Manufacturing and other important stakeholders
Act as project manager for various projects according to customer needs
Act as interim manager for the CMC or Device function
Combining lean tools and domain expertise to make simplified processes which are GMP compliant and ready for digitalisation
Upscaling and process transfer to own Manufacturing or Contract Manufacturing Organisations (CMOs)
Preparation of regulatory strategy and writing of regulatory documents
Evaluation of target company’s CMC and device development strategy including review of key documentation to assist investor in decision making
Solutions adapted to your needs
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