Cost-effective operations and services are ensured through an in-depth knowledge of drug development and regulatory aspects, as well as an extensive professional network providing relevant, associated services. We maintain an excellent authority (USFDA, EMA, SMPA) and customer inspection track record, and up-to-date cGMP compliance.
Quality is the foundation for our work and the trust you confide in us. We have built a comprehensive ICH Q7a compliant Quality Assurance System which is continuously upgraded to meet new requirements. Good Manufacturing Practice is fostered throughout our organization.
We have a dedicated organization responsible for maintenance of the quality assurance system, including review and approval of batch records, validation documents, and SOP’s.
Authorities, official bodies, and clients audit us regularly to verify and certify our quality, equipment, instrumentation, methods and procedures.
We have been fully compliant with the standards of the USFDA, EMA, SMPA and predecessors for more than 40 years.
Our QC is part of the Analytical R&D. QC has the responsibility for analytical testing of raw materials, intermediates and finished products. The testing is made according to established monographs including specifications according to the relevant pharmacopoeias.
Our stringent SOP system regulates the test procedures and result evaluation.
Our QC lab is able to perform all modern analytical testing, according to cGMP.
The quality control department is also responsible for ongoing stability testing.
As a global custom synthesis specialist we will provide you with documents for regulatory filing, compiled to support the registration and marketing of your product.
Our team has the knowledge and experience from different markets around the world so that they can get you exactly what you need.
We provide Drug Master Files (EU and USA), the CMC section of NDA’s, Certificates of Suitability (CEP), Investigational Medicinal Product Dossiers (IMPD’s) and other regulatory documents required in different markets.
We hold ourselves a number of DMF’s and CEP’s filed with the FDA and EMEA.