Drug Substance (API) development

We ensure the core component of your drug product is developed into a smooth manufacturing process.

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The Drug Substance is the essential component of any medicine.

The success of the final drug product starts here, with a robust, scalable synthesis process. We offer hands-on, expert support in navigating the complexities of API development, focusing on efficiency, quality, and regulatory compliance from the earliest stages. We have managed Drug Substance programs across multiple Contract Development and Manufacturing Organizations (CDMOs).

Process development and optimization of the API synthesis route.

Management of API development programs across Contract Development and Manufacturing Organizations (CDMOs).

Ensuring the supply of non-GMP API for pre-clinical studies.

Providing CMC advisory to key stakeholders.

Preparing the necessary CMC data for regulatory filing.

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We help you efficiently introduce your product to the market.

Chemistry,
Manufacturing
and Control leadership

Formulation
development

IND and IMPD for Clinical Phase 1

Quality
Management System

Selection and supervision over a CDMO

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.