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We are
Smart Solutions 44

SmartSolutions44 was founded in 2022 to support our clients in drug product development. As complex as the process can be, we believe in simplicity. Proper knowledge and experience, hard work, and on-time delivery guarantee satisfaction. We will manage your projects precisely that way.

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Our experience

Marek Cichocki

– founder of Smart Solutions 44

I have worked in the pharmaceutical industry for the last twenty years, and drug product development has always been a central part of my professional life. I have extensive experience in formulation development, scale-up, and technology transfer up to a commercial launch.

I can balance the creativity and drive for innovation in R&D with the strict requirements of GMP manufacturing.

I have had the opportunity to manage teams of professionals, both directly and as complex project teams. I know how to build lasting relationships with service and product suppliers.

I gained experience alongside industry experts while working for renowned pharmaceutical companies.

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Selected projects

 

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Preparation of complete Modules 3.2.S. and 3.2.P. for a clinical phase 1 drug  (IND filing at the US FDA)

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Scope of work:

Chemistry Manufacturing Control Drug Substance development IND and IMPD for Clinical Phase Project management Selection and supervision over a CDMO

Drug Substance manufacturing scale-up and first GMP production

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Scope of work:

Chemistry Manufacturing Control Drug Substance development Project management Selection and supervision over a CDMO

Implementation of a Quality Management System at a pre-clinical pharmaceutical company

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Scope of work:

Project management Quality Management System