Selection and supervision over a CDMO
We provide expert oversight to select the optimal partner and actively manage your outsourced programs.
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Successfully outsourcing your drug development and manufacturing to a CDMO is a strategic necessity.
We act as your experienced, internal CMC and Quality team, providing oversight to select the right partner and actively manage the Drug Substance (DS) and Drug Product (DP) programs to ensure technical, quality, and regulatory success.
Identifying and qualifying CDMOs based on project needs, technology, capacity, and quality track record.
Conducting due diligence and quality assurance audits of prospective and current partners.
Negotiating scope, establishing clear project plans, and ensuring seamless technology transfer.
Supervising day-to-day operations, batch execution, and quality-related issue resolution.
Maintaining clear communication and alignment between the sponsor and the CDMO project teams.
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We help you efficiently introduce your product to the market.
We are here to share our knowledge with you.
Call us: +48 690 462 122
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
