Regulatory Affairs

Upon applying for approval of a new drug/biologic application all regulatory authorities require information relating to the manufacture and testing of the drug/biologic This information, also known as “Chemistry, manufacturing and controls (CMC)”, is summarized in Module 3 section of the regulatory dossier.

The continuously evolving CMC regulatory landscape presents a steady challenge to the development of new drugs and biologics. Therefore, it is important for a pharmaceutical company to have an effective CMC regulatory compliance strategy that can meet both FDA and EMA requirements and expectations. CMC regulatory is pivotal in ensuring that drugs being manufactured are safe, effective and of a high quality for patients. At each stage of drug development, from Phase 1 through commercialization, it needs to be determined how to execute all necessary, from a CMC regulatory compliance perspective, activities to get the drug successfully and in the most efficient time schedule through clinical trials into the market without impacting patient safety or creating delays in the program. This ensures the fasted “time to market” while preventing deficiencies in drug product quality and thus preventing clinical holds and market approval delays.

CMC regulatory principally involves writing and compiling regulatory submissions and interacting directly with regulatory authorities. In addition, CMC regulatory advises the CMC team what is necessary at each phase of the drug development.  The creation of CMC documentation requires scientific product and process understanding and the ability to interpret raw data concerning new drugs and biologics.

Progress-PME has strong experience and expertise to support you along the construction of Module 3 of the dossier through approval of the new drug.

Our experienced regulatory affairs specialists and technical writers can support you with writing and compiling the regulatory submissions varying from IMPD’s / IND’s, a first drug application through variations to an existing regulatory dossier. Our consultants have experience with regulatory authority expectations worldwide. In addition, Progress-PME employees can support your CMC project team with respect to the necessary deliverables of each project phase of your development program by performing a Quickscan/GAP analysis and evaluating whether you are still on track or even can speed up your time to market.