Submission management

Regulatory submissions in the pharmaceutical/biotechnology and medical device industry are comprised of documents and data that are submitted to a Regulatory Agency to gain approval to market new drugs, biologics and devices. The documentation represents years of research and includes multi-disciplinary information (including preclinical and clinical data) regarding the safety and efficacy of a compound. The Regulatory process varies from country to country and involves numerous interactions between the submitting company (Sponsor) and the Regulatory Authority (Agency).

The burden of compiling documentation and presenting in a compliant format rests on the sponsor's shoulders. Information is generated from numerous sources including data managemnt systems, medical writing departments, manufacturing sites and external contractors. Once created, the documentation is compiled, published in a compliant format and submitted to the agency. Many regulatory agencies accept electronic submissions in conjunction with or in lieu of submitting paper. The process is complex and requires management of all the component pieces as the submission is compiled and then maintenance of the submission during the approval process and beyond.

Submission Standards

The art and science of managing this process is known as Submission Management. Further complexity has been added as companies move toward electronic submissions and try to implement global standards such as those put forth by the International Conference on Harmonization (ICH). The ICH has developed the electronic Common Technical Document (eCTD) to promote harmonization of regulatory submissions in electronic format across various regions (United States, Europe and Japan). Harmonization efforts are helping to move the industry toward the concept of simultaneous global submissions. Yet, even these efforts are adding to the complexity of the management challenge. In the paper world, much of the effort of managing a submission involved printing and collating volumes of information. In the electronic world, the challenge has shifted focus to management of many submission components, coming from different sources, in different formats at different times. The key to successful submission management involves planning and tracking each component as well as other portions fo the submission that may be related or dependent. In addition to planning and tracking content, it is also important to manage and allocate resources effectively based on workload, skill sets and availability. The planning, tracking and management of all of these moving parts throughout the drug development process has motivated companies to begin to look at submission management as a formal discipline and to start analyzing metrics behind their submission processes. Submission Metrics

One of the biggest challenges of submission management is finding a way to collect metrics during a traditionally frantic and sometimes chaotic process. There can be thousands of components included in a regulatory submission and each must meet certain compliance criteria. Compliance requirements are dependent on the type of application being submitted, the region/country where the application is being submitted and the format of the application. Each component must also be tracked from creation, through development to completion and approval for submission. As Submisison Management professionals (often referred to as Dossier Management) attempt to monitor and track progress toward completing a submission, they must monitor resource constraints, content issues, compliance concerns, and any recent agency interactions that may impact the final submission.

A regulatory submission is mission critical to a pharmaceutical, medical device or biologics company. For this reason, this area is starting to get more focus and attention as companies look for ways to increase efficiencies and cut time and costs in the drug development processes. The competitive nature of the industry is forcing companies to "get better at submission management".

Resources

There are software vendors who have developed submission management software to assist in the automation, tracking and management of the complex submission process. There are also consultants who will help companies develop best practices for defining processes, collecting metrics and analyzing current capabilities to see where the submission process may be improved.

Related Links
* [http://estri.ich.org/eCTD/eCTD_Specification_v3_2.pdf ICH eCTD Specification V 3.2] (The specification)
* [http://estri.ich.org ICH M2 ESTRI Main]
* [http://www.fda.gov/cder/regulatory/ersr/ectd.htm electronic Common Technical Document (eCTD)] (FDA)
* [http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm EUDRALEX Volume 2 - Pharmaceutical Legislation : Notice to Applicants] (EU legislation, contains section on eCTD)
* [http://cdisc.org Clinical Data Interchange Standards Consortium (CDISC) website]