Our research and development activities mainly take place in our headquarters in our branch office in Nanjing. By the 1st May 2009, our research and development team have 42 research scientists and technicians, and over 30% of which are qualified to PhD level. Respectively a broad range of relevant synthesis and testing equipment are available to develop new processes. Our R&D activities focus on improving the product quality, reducing the manufacturing time and lowering manufacturing costs.
Development of new production processes is highly integrated with quality assurance procedures, which include strict record keeping of all procedures and monitoring procedures to ensure the consistent application of our manufacturing processes. We maintain quality control manuals for internal distribution among our factory managers and employees to maintain consistent practices. Several major international pharmaceutical companies have audited our facilities and independently issued third-party reviews.
◇ The Departments have three main functions :
【a】Synthetic Research and Process Development;
【b】Analytical Research and Development;
【c】Kilo-lab and Pilot Production.
◇ This professional research team develops new synthetic routes and supplies lab samples of new compounds or generic API's according to scalable and no-hazardous processes. It also optimizes and scales up synthetic processes through lab work and pilot production. It has gained customers’ recognition by some exceptional achievements, made possible by the team’s dedication and expertise. We see its relatively small size as the best option to guarantee efficiency without bureaucracy.
◇ The kilo-lab and pilot plant are equipped with vessels ranging from 20 l to 600 l. Processing temperature conditions can range from -80°C to + 300 °C and the synthesis can be carried out under strict cGMP rules.These equipments are the replica of the industrial equipment in the production plants at a scale of 1 to 10. This makes scale-ups and operating processes easier, faster and more reliable.
◇ Research, industrial development and manufacturing teams are located on the same site and they liaise permanently for fast industrialization and quick troubleshooting.
◇ The Analytical R&D is equipped to support the process development and DMF registrations with HPLCs, GCs, IR & UV, GC-MS. Chemieliva has also validated sub-contractors under CDA for other analyses such as NMR, specific surface, platinum content.
◇ The R&D department also maintains cooperation agreements with Universities. This enables Chemieliva to validate and use the latest technologies in organic synthesis, as well as to access specific expertise