CORPEX builds regulatory affairs software to streamline the often complex workflows in research and development (R&D) and regulatory affairs. These solutions encompass features to manage projects, track experiments and vital data, facilitate collaboration among researchers, and support the CTD dossier management a registration submission depends on.
On the regulatory side, CORPEX's software helps document requirements, track submissions to agencies, and maintain compliance throughout the product lifecycle — from first formulation record to post-approval variation and renewal.
R&D managers, formulation scientists and regulatory affairs officers inside pharmaceutical manufacturers are usually working from the same underlying product, but from different systems: a formulation binder here, a stability report there, a regulatory affairs officer's own spreadsheet tracking what has been filed where. Regulatory affairs software exists to close that gap, so the record a formulation scientist builds is the same record a regulatory officer cites in a dossier.
CORPEX's regulatory product suite covers both sides of a product's regulatory life. RENOVA-RDX is pharmaceutical R&D software for formulation, analysis, stability studies and CTD dossier management before and during registration. InFlow-PV picks up after approval, centralizing product information, complaint handling, literature tracking and safety data for pharmacovigilance. Together they cover a product from first formulation record to the safety reporting a marketed product requires.
Most agencies, including the Egyptian Drug Authority, register pharmaceutical products against the Common Technical Document (CTD): Module 1 for administrative and region-specific information, Module 2 for overview summaries, Module 3 for quality data (formulation, manufacturing and analytical information), Module 4 for nonclinical study reports, and Module 5 for clinical study reports. Module 1 is the one module that is never harmonized — each authority sets its own administrative, labeling and pricing requirements for it, which is why a dossier built for one market is not automatically ready for another.
Registration is not a one-time event either. Any change to formulation, manufacturing site or specification after approval normally requires a variation filing, and most registrations expire and have to be renewed on a fixed cycle — each with its own dossier update and deadline. Regulatory affairs software has to track all of it at once: which dossier version is on file in which market, which variations are pending, and which renewal deadlines are approaching, without relying on one person's memory of what was filed when.
RENOVA-RDX is pharmaceutical R&D software designed to maintain a comprehensive overview of R&D and regulatory affairs across a number of products within multiple dosage forms — formulation, analysis, stability studies and CTD dossier management in one system.
The InFlow-PV application offers numerous benefits, including centralized product information management, streamlined file tracking and reporting, efficient complaint handling, enhanced literature tracking, and flexible data extraction and sharing. These features collectively contribute to improved pharmacovigilance processes, regulatory compliance, and proactive monitoring of product safety and quality.
The dossier a regulatory affairs officer submits is only as good as the data behind it. In RENOVA-RDX, a formulation is recorded and version-controlled, then analytical methods, specifications and Certificates of Analysis are attached to that formulation version. Stability studies run against the same product using stability LIMS software scheduling and chamber monitoring compliant with ICH guidelines, producing the shelf-life evidence a CTD Module 3 quality section needs. Only then does the Regulatory Affairs module compile the dossier, drawing on the formulation, analysis and stability records already on file, and keep registration tracking, renewal alerts and correspondence with authorities current after submission.
This is the same connected workflow CORPEX runs for its wider pharmaceutical software solutions — QC laboratory data, quality records and regulatory dossiers on one platform, so nothing has to be re-entered between the lab, the quality system and the regulatory file.
An Egyptian Drug Authority (EDA) registration dossier is built to the same CTD structure described above, with Module 1 carrying the EDA's own administrative documents, labeling and pricing information. An Egyptian regulatory affairs team is rarely tracking one product: it is tracking a portfolio, each with its own registration date, pending variations and renewal cycle, on top of the EDA's own correspondence and query history. Regulatory affairs software that only stores documents does not solve that problem — it has to track dossier status, variations and renewal deadlines per product, per market, on an ongoing basis.
CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital, and its regulatory affairs software is deployed with Arabic-speaking implementation and support, on-site configuration, and contracts in Egyptian Pounds. RENOVA-RDX is validated on-site before go-live through computer system validation (CSV), so registration tracking, renewal alerts and dossier records hold up to an EDA inspection from day one. For the full local picture, in English and Arabic, see regulatory affairs software in Egypt.
Combining R&D and regulatory affairs solutions offers a powerful one-two punch for businesses.
Software can manage projects, track experiments, and facilitate collaboration, accelerating the innovation cycle.
Centralized data storage and analysis lead to better decision-making and improved product development.
Automated tasks and workflows free up researchers' time for core activities, maximizing their productivity.
Software can ensure compliance with regulations, minimizing the risk of costly delays or rejections.
Automated tracking of submissions and streamlined document management save time and resources.
Clearer visibility into the regulatory process allows for better planning and informed decision-making.
Overall, these solutions can significantly improve the efficiency and success of both R&D and regulatory affairs efforts, ultimately bringing innovative products to market faster and with greater compliance.
Regulatory affairs software is a system for compiling registration dossiers, tracking submissions and approvals across markets, managing variations and renewals, and keeping correspondence with health authorities in one auditable record instead of spreadsheets and shared folders. CORPEX's regulatory affairs software is RENOVA-RDX.
RENOVA-RDX covers R&D and regulatory affairs — formulation, analysis, stability studies and CTD dossier management and registration tracking. InFlow-PV covers pharmacovigilance after a product is on the market: centralized product information, complaint handling, literature tracking and safety reporting. The two connect the pre-approval and post-approval sides of the same product record.
An Egyptian Drug Authority (EDA) registration dossier follows the CTD structure, with Module 1 carrying Egypt-specific administrative, labeling and pricing documents. Regulatory affairs software needs to track the dossier version submitted for each product, outstanding variations, upcoming renewal deadlines, and every piece of correspondence with the EDA — which is what RENOVA-RDX's registration tracking, renewal alerts and correspondence tracking are built to do.
Yes. Because RENOVA-RDX is part of the CORPEX platform, formulation, analysis and stability data connect to Certificates of Analysis and specification data from CORPEX-LIMS, and to the SOPs and change controls that live in CORPEX eQMS, without re-keying between systems.
Yes. RENOVA-RDX implementations go through CORPEX's computer system validation (CSV) service — a Validation Master Plan, IQ/OQ/PQ execution and traceability from user requirements to test evidence — so the system holds up to inspection from day one.
Yes. CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital, and its regulatory affairs software is deployed with Arabic-speaking implementation and support, on-site configuration, and contracts in Egyptian Pounds for teams across Egypt and the wider MENA region.
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