Is it possible to perform quality testing or contract manufacturing of controlled substances in SIA Nothern Synthesis facility?
Yes, it is possible upon request.
Are you regularly inspected by authorities?
Yes, a competent national authority, the Latvian State Agency of Medicines, regularly audits the quality of our manufacturing systems. As Latvia is one of the member states of European Union, our manufacturing systems comply with the regulations of international standards.
Which type of API is the company manufacturing?
Our manufacturing process is chemical synthesis. Production begins with an introduction of starting materials into process, and then continues with the production of intermediates, isolation, purification and packaging of the final product.
Which GMP standards is the manufacturing of API subject to?
Our API manufacturing comply to GMP standards of EMEA ICHQ7A guidelines “Note for guidance on good manufacturing practice for active pharmaceutical ingredients”.
Which pharmacopoeia requirements do your API products meet?
The quality of our final API products meets pharmacopoeia requirements of respective monographs of E.P. or USP.
What is the shortest possible lead time?
The lead time depends on the quantity and the product ordered and whether we have it in stock readily available.
Do you welcome client’s inspections?
Yes, we welcome client’s inspections both on-site and remote desktop audits.