Since 2008, the FDA has encouraged drug companies to submit regulatory applications electronically using the electronic Common Technical Document (eCTD) format. After use for more than ten years, the eCTD format is widely considered a remarkable success.
With growing industry popularity for the eCTD format, as well as regulatory agencies' clear preference for it, now is the best time to transition away from the paper format:
- eCTD standards significantly improve organization, enhance search functions, and ease content retrieval
- eCTD provides lifecycle management at both submission and document levels
- eCTD improves storage, archiving, and transfer of data
Mapi's eCTD submission management system results in improved quality for your submissions, increased efficiency, and thoroughness during the review process. Our eCTD services also expand communication at CRO-sponsor, sponsor-agency, and agency-agency levels.
Changing Guidelines Demand an Experienced Partner
In May 2015, the FDA published the final guidance enforcing the eCTD standard as a required submission format for most submissions. With ever-changing eCTD specifications, new regulations, and an enormous cost of required infrastructure for the preparation and maintenance of electronic submissions, electronic filings can pose daunting challenges for companies trying to get their products through the approval process.
Mapi has been providing electronic submission services since 1999, when the first FDA guidance for electronic submissions was published. We support clients with services that cover the full scope of the global eCTD system, including preparation, hosting, training, management, and strategy. Mapi offers a process-based approach to eCTD compilation. Using top industry tools and efficient internal procedures, our global regulatory affairs team ensures that your electronic submissions are clear, thorough, and fully compliant.
Mapi Simplifies eCTD Mandate Compliance for Smaller Businesses
With the FDA deadline of 2017 fast approaching, now is the time for smaller businesses to begin collaborating with Mapi for the successful conversion and filing of eCTD submissions.
Building in-house eCTD processes, systems, and expertise is a relatively easy task for large companies, but smaller teams may encounter substantial challenges. Electronic publishing requires different processes, more sophisticated systems, a greater level of computer skill, and experienced regulatory staff. The systems necessary for effective management and publishing of regulatory documentation also require substantial capital investment, with costs related to purchasing, installation, initial validation, training, and on-going costs for system support, personnel, periodic upgrading, and revalidation.
Larger pharmaceutical companies with high submission volumes may have a compelling business case for implementing and maintaining an in-house regulatory operations team and publishing system, but these costs are far more difficult for smaller companies to justify. As a result, outsourcing is an attractive option for these companies.
Our regulatory experience and industry expertise makes Mapi the best choice to help you navigate these obstacles and produce clear and effective eCTD submissions.
Outsourcing with Mapi: A Flexible, Cost-Effective Solution
The cost of purchasing, validating, maintaining, and operating a small in-house regulatory document management and a publishing system is estimated at anywhere from $250,000 to $800,000 for the first year, and then $100,000+ every year thereafter. Additionally, other variables need serious consideration, including the number of products and their current stage(s) in development, the status of any partnering, and any need for documentation gap analyses, to ensure thorough completion of the product dossier(s).
Smaller companies with a low annual submission volume can expect significant savings via outsourcing their regulatory submission publishing/management using Mapi support.
The knowledge and experience of a good service provider is invaluable
Many service providers that offer a contract publishing service are established specialists, with well-trained teams and extensive eCTD experience whose extensive practical experience has facilitated optimized working practices, resulting in processes that meet higher standards of quality more efficiently. Companies investing in an in-house system will discover a steep learning curve associated with the submission publishing process, which will force them to allot additional time for personnel to understand new processes and resolve any initial problems with implementation. Developing and overseeing an effective electronic regulatory document management and publishing system is time-consuming, complex, resource-intensive, and may take many months.
Benefits of Outsourcing with Mapi
Working with an experienced eCTD outsourcing solution like Mapi is essential to reducing submission costs, increasing process flexibility and access to specialist expertise, and providing regulatory sample submission circumvention.
While outsourcing costs for publishing can vary depending on the submission’s size and complexity, outsourcing with us can cost a mere fraction of an in-house system budget. Companies that choose Mapi as their eCTD regulatory service provider benefit from access to our specialists' knowledge and experience, with plenty of learning opportunities to expand a company's in-house services.
Mapi's experienced teams and extensive capacity can more likely assure successful project delivery within a significantly shorter timeframe than what might be expected of a smaller in-house team. Mapi supplies you with highly capable field experts who oversee a variety of rigorous and reliably compliant regulatory services to fully ensure product success and stability.
- While preparation costs for an initial electronic submission can be substantially greater than what is required for a paper submission, submission costs over the product’s lifetime are much lower (using the electronic format) with Mapi's support.
- Printing and shipping costs are eliminated, as are the costs of maintaining your own repository of paper copies.
- Mapi's Electronic Secure Gateway (ESG) offers automated eCTD processing, reducing submission acceptance wait-time to only fifteen minutes!
- Multiple users can access the documents simultaneously—eliminating the need to share paper volumes or make extra copies.
- Clients are offered the advantages of easy cross-referencing with Mapi's extensive database resources.
- Certain documents can be re-used with the aid of cross-application hyperlinks.
- eCTD submissions help reduce review times, leading to faster product approval for Mapi clients.
- Mapi can submit applications in multiple countries and multiple languages with relatively minor changes.
- Most FDA reviewers prefer eCTD format to paper documentation.
- Mapi maintains and makes available a file storage network for entire submitted/published applications, allowing clients easy, 24/7 access from any location with a secure internet connection.
Breaking the Outsourcing Myth
- Since an eCTD submission is inherently portable, entrusting an initial eCTD submission to Mapi does not mean being locked into a long-term relationship with us for subsequent maintenance.
- An eCTD submission is independent of the software used for its creation, therefore any eCTD that complies with ICH and regional specifications can be managed using any software package designed for this purpose. Thus, after outsourcing an initial eCTD submission to one service provider, companies may select a different provider for maintenance or bring the activity in-house
Mapi: The Right Choice for your eCTD Submission Needs
Outsourcing eCTD publishing can be attractive to small- and medium-sized companies lacking a strong business case for investing in their own regulatory documentation submission management system. In this endeavor, Mapi is the best choice.
Our specialists follow the best practices for outsourcing – including providing a detailed definition of the project scope, selecting an experienced and reliable service provider, proactive project management, and robust procedures for document version control and traceability.
Outsourcing your eCTD management to Mapi results in optimized outsourcing, and more efficient and successful regulatory documentation approval for your organization and your products in development.