Regulatory and Software Services
In today’s regulatory environment, companies must wade through numerous complex steps in the submission process. CSC helps you manage these expertly with professional services that take you from analysis of data and preparation of documentation all the way through to compilation of final submissions.
Our services portfolio spans data management, regulatory affairs and regulatory writing. Whatever the format (eCTD, paper or NeeS) and whatever the approach — first-time submission, conversion of paper to eCTD, or reuse of a regulatory submission from one market to another — CSC's time-tested methodologies ensure a project will be a success.
With extensive global resources from which to draw, our expert team has deep domain expertise in multiple therapeutic categories such as autoimmune, cardiovascular and infectious diseases; in oncology and neurology; and in drugs, devices, gene therapy and genetics.
CSC has compiled thousands of regulatory submissions in more than 72 countries, including more than 6,000 eCTDs. We commit to accuracy in all we do, and as a result, we have never had a refusal to file based on errors in submission compilation. In addition, our long-standing relationships with CDISC and Health Level Seven International (HL7) give our clients access to industry best standards.