| |
|
| |
| Pilgrim Regulatory Submissions -- Enabling electronic submissions to accelerate your product approvals and time to market |
Life Sciences companies frequently experience lengthy approval delays as they bring new products to market. Today, submissions to multiple regulatory bodies are often prepared and submitted through a manual, paper-based process whereby managing the lifecycle, tracking changes, assembling and submitting the right data can be a challenge. Pilgrim’s Regulatory Submissions solution provides complete lifecycle management for your regulatory submissions. Whether you’re managing NDAs, ANDAs, MAAs, INDs, BLAs, PMAs, or 510(k)s and other submissions, Pilgrim’s solution fully provides all the elements needed for global electronic submissions needs including eCTD or non-eCTD electronic submission (NEES), and will help global organizations prepare for the global mandates by regulatory agencies.
Pilgrim Regulatory Submissions manages document/submissions lifecycles
Pilgrim’s Regulatory Submissions solution puts the focus where it belongs – squarely on creation and management of documents necessary to deliver compliant electronic submissions to regulatory agencies in a constantly evolving industry. With this solution,
- All content that is relevant to a submission can be secured, tracked and managed with complete review cycles, approvals, change management and appropriate signatures for both unstructured and structured content.
- Regulatory managers can easily set up visual virtual files folders reflecting the required outline structure of each of their submissions.
- Files can be easily shared from one regulatory agency submission to another.
- Organization work teams can easily collaborate to plan, create, edit and generate drafts that are managed in a central repository, allowing a company to gain efficiency by making information quickly accessible and easily reusable for new submissions.
Pilgrim Regulatory Submissions streamlines and automates submission business processes
Pilgrim’s Regulatory Submission solution is designed to seamlessly integrate with an organization’s existing business processes and integrates with existing infrastructure. This helps organizations leverage their existing investments and processes while being able to comply with the global electronic submission needs. Regulatory users can continue to use the existing processes and skill sets, and focus their efforts towards generation of the content, and the system will automate the generation of the necessary XML, checksums, DTD and other necessary technical translation. This helps minimize the training effort and ensures that the regulatory users fulfill their role as the content experts without being distracted by technical requirements.
Pilgrim Regulatory Submissions supports high quality and seamless assembly/publishing
Quality assembly and rendering is essential to the success of any regulatory submission, helping improve the negotiation and approval process with regulatory reviewers and accelerating internal submission timelines. Pilgrim Regulatory Submissions:
- eliminates multiple rounds of review, publishing and quality control checks
- makes assembly of a global Electronic Submission a seamless process
- provides integrated submission and document level publishing features, including automatic generation of backbone file and regional information, checksums, bookmarks, table of contents, hyperlinks and others, and functions for paper publishing
Pilgrim Regulatory Submissions enhances quality control and timely distribution
Quality control and distribution are critical to ensure quality submissions are sent to the agencies within the timelines. To minimize errors, users can easily view and validate the submission to verify the accuracy, completeness and validity of the package and conformance to agency guidelines. Issues with the submission are readily visible within the solution. Once validated, the submission can be prepared for media and final packaging.
The Integrated Compliance Platform
Pilgrim’s Regulatory Submissions is a fully-integrated part of the Pilgrim Software’s Enterprise Compliance and Quality Platform. Pilgrim Software provides an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external audits, document control, SOP enforcement, engineering collaboration, employee certification and training, equipment/calibration, supplier quality management, advanced quality planning and risk management.
This powerful solution enables you to manage quality and compliance
across your entire business, helping you meet regulatory requirements,
increase efficiency and reduce costs.
E-mail
this page
Print This Page | |  |
 |
| |
Get
more information about Pilgrim Solutions.
