Quality is reflected in everything we do at Syntagon. Our facility in Södertälje, Sweden, fully operates under Good Manufacturing Practice (GMP) while our facility in Pinki, Latvia, is GMP certified for quality control of API's. We are audited regularly by European Medicines Agency (EMA) and are fully compliant in the manufacture of APIs in accordance with regulatory guidelines (EMA/FDA). In addition to this, we host many audits from customers throughout Europe and North America.
Our organizational set-up, documentation, equipment, procedures, processes and people are all aligned to ensure that your API meets the agreed specifications for strength, purity and identity. For you, this means speedy regulatory approval, and the confidence of passing a due diligence process of even the most critical partner.
At the heart of our operations is a reliable, user-friendly quality system. Its ease of use, including standardized protocols and checklists, guarantees that quality is woven into the fabric of the entire company.
Our QC laboratory will test and evaluate incoming raw materials, manufactured intermediates and API. In addition our QC staff have the capability and experience to develop and validate analytical methods and perform stability testing of API batches or intermediates according to ICH guidelines. Our customers frequently request these services accompanied by our comprehensive analytical method development-, validation- and stability reports.
This fully integrated quality management system ensures that, with Syntagon, quality is never an issue.
Chemistry, Manufacturing and Control (CMC) is part of the regulatory file that deals with the characterization of an API (chemistry), its production (manufacturing) as well as the reliability and reproducibility (control) of the produced batches. At Syntagon, we closely monitor changes in regulatory requirements and incorporate these new principles in a timely fashion. We will keep you updated and work proactively with you to make sure that the CMC file will pass even the most stringent reviews.
Syntagon compiles all relevant information in a format ready for the CMC dossier – both in US (IND) and EU (IMPD) formats. Based on our extensive experience, we will propose a level of information appropriate for the intended stage of trials. This allows us to streamline the process so that our document compilation – and your compound’s approval – is certain to avoid any unnecessary delays.
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Phone: +46 8 554 422 50
SE-151 02 Södertälje
Visiting & Delivery address
SE-151 38 Södertälje
Phone: +371 67 490 881
Postal and Visiting address
Syntagon Baltic SIA
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