Regulatory Affairs (RA) involves the responsibility of professionals to monitor an organization’s compliance with the current, applicable rules and laws, and to develop a strategy for communicating with regulators. When applying for approval for a new drug/biological application, regulatory authorities require information about non-clinical and clinical data as well as on manufacturing and testing of the drug/biological. This information is assembled in the common technical document which is composed of five modules:

• Module 1: Regional administrative information
• Module 2: Summaries and overviews of Quality, Non-clinical and Clinical Data (of Modules 3, 4, 5)
• Module 3: Quality Manufacturing data
• Module 4: Non-clinical data and Toxicology studies
• Module 5: Clinical data

Progress specializes in Module 3 of the regulatory dossier, which also refers to Chemistry, Manufacturing and Controls (CMC).

The ever-evolving CMC regulatory landscape poses a steady challenge to the development of new drugs and biologics. Therefore, it is important that a pharmaceutical organization has an effective CMC regulatory compliance strategy that can meet the requirements and expectations of the applicable regulatory authorities, for example the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). CMC regulations are critical to ensure that the medicines being manufactured are safe, effective and of high quality for patients. Progress can provide effective input for the required documentation.

At each stage of drug development, from Phase 1 through commercialization, all activities necessary to bring the drug to market through clinical trials in a timely and successful manner should be defined from the perspective of compliance with the applicable regulations, without compromising patient safety. This ensures a fast time-to-market while preventing deficiencies in drug product quality, thus preventing clinical holds and market approval delays.

CMC regulatory primarily involves writing, compiling regulatory submissions, and interacting directly with regulatory authorities. In addition, the CMC regulator advises the CMC team what is needed at each phase of drug development. Creating CMC documentation requires scientific understanding of products and processes and the ability to interpret raw data on new drugs and biologics.

Progress has strong experience and expertise to support you in constructing Module 3 of the dossier through the approval of the new drug. Our experienced CMC specialists and technical writers can support you in writing and compiling regulatory submissions ranging from IMPD’s/IND’s, an initial drug application to variations to an existing regulatory dossier. Our consultants have experience with the expectations of regulators worldwide. In addition, Progress staff (Consultancy, Project Management, Temporary Staffing) can support your CMC project team regarding the necessary deliverables of each project phase of your development program by performing a Quick Scan/GAP analysis and evaluating whether you are still on track or even your time-to-market can accelerate.