Who is DSI?
DS InPharmatics (DSI) offers expertise in Regulatory Affairs, Chemistry Manufacturing and Controls & Quality Assurance. Our consultations cover a wide range of real-world experience, focused on quality-based manufacturing, analytical method development, validation and troubleshooting, formulation development, stability strategy and evaluation. In addition our Regulatory Affairs staff ensure that all of the above CMC practices are carried out in agreement with regulatory agencies requirements and expectations.
Since such requirements and expectations change with time, CMC regulatory compliance is to ensure that all of the above CMC practices are updated accordingly, in order to ensure that if the company has made any CMC specific commitment to the regulatory agencies, either verbally or in writing, that such CMC practices are carried out.