CMC Regulatory DB includes:
- Covers 120 countries’ regulatory requirements for CMC spanning Clinical IMP to Registration and Post-Approval requirements
- Granular details included 50+ CMC data points
- For Post-approval, search by change (use either free-text or filters) to get change specific requirements and documentation needed for submissions
- Health Authority documents included as well
- Do your change impact assessments faster?
1. Identify the Change: The first step in CMC impact assessment is to identify the change that is proposed. This could include changes to the manufacturing process, raw materials, product formulation, or analytical methods.
2. Determine the Potential Impact : Once the change has been identified, the potential impact on the quality, safety, and efficacy of the drug product must be determined. Tool will suggest the likely impact based on the country and propose the required documents needed.
CMC impact assessment is an important step in ensuring the quality, safety, and efficacy of pharmaceutical products. By utilizing our impact assessmentmodule, drug manufacturers can make informed decisions and implement changes in a controlled and effective manner.
Is CMC Authoring a Technical Art / Science?
YES: For documents like a Strategy document, CMC Plan and some parts of Mod 3
NO: For documents like a QOS, Stability Reports, DSR and life cycle changes (that depend on master documents), and few others
YES category: For initial/first document creation, REGai REGai saves about 10% of time by getting right template and pooling any data that is needed to refer for document creation. In life cycle (changes and versions) of these documents, REGai saves over 40% of the time. Extend the savings by another 30% using QC and Publishing features of REGai.
NO category: REGai saves over 50% of the time as most documents are created automatically from source documents or source data (from your different databases or REGai can digitize your old documents for reuse using our NLP engine). Extend the savings by another 30% using QC and Publishing features of REGai.
Writing UI: Meant for Authors user interface is made as close to Word as possible. As some of them need deep collaboration, you will have options to add workflows, QC, alerts and trackers.
Data: Data (from change control, or LIMS or Excels) needed for some of your documents, pull and add directly into Documents with simpler rules built-in and several connectors in place already.
Automation: Customized flows and screens provided for some of your most common documents to save you doing manually (of adding this or pulling that or referring there).
Change Management: Regulatory change management is included where variations can be proposed, created, and tracked until implemented in the core labels. Changes proposed for core labeling processes are extended sequentially to the processes at each level (LPD, Artwork, Printing, and Supply Chain). Our solution can recognize the countries impacted by the proposed labeling changes and notify the concerned stakeholders on the change, well before the CCDS distribution.
Publishing : Reduce your publishing pain (and save your time) by leveraging publishing module to get your submission ready output files in minutes. Download to your Desktop or use our pre-built connectors to push published documents to SharePoint, Documentum, BOX, and other 3rd party Sources.
Templates : Robust template management incorporating several Libraries / CVs to standardize TOC (or bring your own standards). Create your templates in minutes (without programming/coding involved).
Access: Cloud (hosted on Private Cloud in USA/Germany).
Word is undoubtedly the world’s most popular word processing program.
You’ve got your document formatted exactly to specifications: titles are properly bolded, headers/footers with margins all well aligned, page/section breaks in place, bullets sit in perfect lines. Then you insert just one troublesome table or footnote — everything is shot. Goodbye beautiful formatting; goodbye well-arranged page.
What seems to be a ‘simple’ edit has added 18 minutes of formatting time.It doesn’t have to be like this.
REGai automates document formatting and most documents are auto-formatted in SECONDS. With 300+ extensive rules library, you pick and create your custom plans with flexibility of applying what/when to your documents on the fly. You are in control as all this is done using a simpler user interface that’s cloud-based (or can be run as batch connecting to your EDMS or RIM systems).
ROI / Savings: 70% and above compared to your current manual costs. Guaranteed!
Formatting Rules: Standard Out-of-box rules for most country requirements like FDA, EU, and other regions +you can use any custom formatting rules from our vast library on DOC or PDF (Layout, Style, Header/Footer, Tables, TOC, Bookmarks, Hyperlinks, and more).
Mode: You can do Real-time or run as Batch.
File Sources: Upload from your Desktop or use our pre-built connectors to SharePoint, Documentum, RIM, and several 3rd party Sources.
Download: Source/Output files and Formatting Report, Output files are available as ZIP or have REGai upload to your EDMS or your servers.
Access: Cloud (hosted on Private Cloud in USA/Germany) For high-volume work, on-prem available.