iRegOperations Advantages
We have a proven track record of several thousand successful submissions – meeting even the most challenging submission deadlines.
iReg Operation is the Global Publishing Services initiates right from dossier development that includes Regulatory submission planning, tracking, publishing, and making the final submissions to Regulatory Authorities including delivery confirmation/acknowledgment.
- The eCTD submission process is often a significant, costly barrier in the product development lifecycle. It is required by FDA for Original application for INDs, NDAs, ANDAs, Amendment, SPL, Facility Registration, DMFs, eCopy for medical device submissions, EMA, MHRA, Swiss Medic, TGA, Health Canada and other EM regulatory authorities.
- A dedicated submission expert will be assigned to each of your projects, acting as your single point of contact and lead coordinator of the project with Pearl Pathways’ internal regulatory and publishing team.
- Company don’t have to make any upfront investment in the technology. They are only paying for the service in short you are only paying for manpower thereby saving a lot of capital which can be used for R & D activity.
- Individual don’t have to worry about breakdowns and heavy Annual Maintenance contracts (AMC) and frequent FDA updates on the systems so it’s a big plus over there.
- Outsourcing works on pay as you go basis, so you are paying only for actual submission you make in a year so if you don’t plan any submission, you don’t pay anything.
- You won’t need to train or hire eCTD experts in your company reducing your company’s permanent employees and saves tremendous amount of money, reduce your administrative and resources burden.
- Small companies with less than 10 submissions (small companies) in a year will be the biggest beneficiary of this model.
- This also benefits for large companies to compile big volumes of submission which require eCTD software, AMC and do all the hard work with training and implementation of systems with 21CFR Part 11 Compliance.
- Country-specific composition, publishing, and validation for submissions in the US, EU, Japan and other countries.
- To streamline the entire Regulatory Publishing and Submissions management process.
- A commitment to quality, efficiency, transparency and our customer needs.
- Multiple level QC checks at document level and submission level publishing
- Continuous Project Monitoring and Management.
- Conversion services: Bring your existing NeeS submissions into eCTD.
- Document authoring and medical writing services.
- Storage and archival of the eCTD file on our secure 21 CFR Part 11 compliant server
Structured Product Labelling (SPL)
SPL is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format.
Other services such as Establishment Registration, National Drug Code (NDC) Labeller Code etc.
Training Programme for Regulatory Operations
iCretegy training program: Offer for Regulatory Operations aspects for Document-level publishing (DLP) & submission-level publishing (SLP), publishing Strategy, submission dispatch activity and eSubmission troubleshooting to file the successful electronic regulatory applications.