CMC and Device Development

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

Product and Process development

Drug Development:

Quality by Design framework

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  

Device Development:

Design Control framework

Design and Development Planning, Design Input, Design Output, Design Verification, Process Validation, Design Validation and Design Transfer 

Combination product development:

Streamlined approach

Requirements for drug and device combined into a streamlined process 

CMC and Device strategy

Preparation of global CMC and Device strategy that is aligned with Clinical Development, Manufacturing and other important stakeholders 

Project management

Act as project manager for various projects according to customer needs 

Interim management

Act as interim manager for the CMC or Device function 

Process simplification

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

Upscaling and process transfer

Upscaling and process transfer to own Manufacturing or Contract Manufacturing Organisations (CMOs) 

Regulatory Affairs

Preparation of  regulatory strategy and writing of regulatory documents 

Due diligence

Evaluation of target company’s CMC and device development strategy including review of key documentation to assist investor in decision making 

Customised solutions

Solutions adapted to your needs

Interested to hear more?