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ChemCon's Pharmaceutical API Services cGMP

ChemCon’s clear focus is the niche of high-quality cGMP manufacturing in gram to multi-kilogram batches. Over the past twenty years, a large number of very individual and very different projects allowed us to build sound experience in cGMP process development in organic, inorganic and polymer chemistry. This comparatively broad spectrum allows us to respond flexibly to your individual needs and react to current regulatory trends and changes. For example, we notice that more and more of our customers are challenged by recent increases in regulatory demands not only for APIs but for excipients, provocation substances, dietary trace elements, or delivery agents – even already registered ones. For all of these substances, from simple inorganic trace-element salts to polymeric delivery agents, you benefit from ChemCon’s experience to readily establish cGMP compliant processes.

Increasing regulations also apply to the Supply Chain. If your project requires, ChemCon will also synthesize your key-starting materials to comply with the regulatory demands of your process.

Despite the best experience, the course of new projects, in particular development projects for new chemical entities (NCEs), is sometimes difficult to predict. Requirements, both by yourself and/or regulatory authorities can change fast and suddenly.

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To keep your project as flexible as possible:

  • each inquiry is evaluated individually
  • detailed, tailor-made offers provide a trans-parent overview over expected timelines and costs
  • development modules may be ordered subsequently, allowing flexible changes at any time
  • your project manager will provide you with a weekly project report

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Project overview:

 

 

 

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