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Regulatory Compliance, Quality Assurance and Control

Chemoswed ensures total regulatory compliance, along with quality assurance and control.

Quality assurance

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 organisation. We have a dedicated organisation responsible for maintenance of the quality assurance system, including review and approval of batch records, validation documents, and SOPs. 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 FDA, the EMEA and predecessors for more than 40 years.

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Quality control

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.

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Regulatory compliance

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 diles (EU and USA), the CMC section of NDA’s, certificates of suitability (CEP), investigational medicinal product dossiers (IMPDs) and other regulatory documents required in different markets. We hold ourselves a number of DMFs and CEPs filed with the FDA and EMEA.

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