Information About

Regulatory Operations

Corporate mergers, aquisitions, downsizing and other industry overhauls usually result in all sorts of document management issues. Poor documentation could prevent your product from being registered or it may have your marketing application delayed. It could also lead to legal ramifications or having your marketed product withdrawn from the market, be it a multi-billion dollar product or a few thousand dollars product. Harmonization efforts in Electronic Documentation are gaining popularity worldwide. Good document management of hard-copied documents are also worth having.


Adlib Software : Provides Enterprise Content Transformation, enabling the worlds largest organizations by improving the efficiency, quality and control of business processes with content to PDF transformation solutions to optimize productivity, mitigate risk and reduce costs.

CTD Australia (TGA) : The TGA only accepts applications to register prescription medicines in the Common Technical Document (CTD) format.

CTD_ICH : Moduole 4: M4 Common Technical Document

Document Solutions : Ricohs Document Solutions include document management, storage, image scanning, file conversion, and collaboration.

Documentum : Content Management: EMC software provides a wide range of solutions that manage content across multiple departments within a single repository.

Documentum e-Room : To remain competitive today, product and service companies need to work as efficiently as possible across functional, geographic, and organizational boundaries.

e-Document -Data Entry : Ranging from low volume, desktop products to high-volume, enterprise-level products, Captiva's offerings have a common mission: relieve the burden organizations face in feeding their information-intensive systems faster, more cost effectively, and with greater accuracy.

e-Document Capture : OCR software improves the efficiency and accuracy of your data entry. Datacap OCR software provides the highest possible data recognition accuracy at high speed and high document volume.

e-Document Compression : Perform Compression, Conversion, and OCR with an All-in-One Solution for Your Documents and Images.

e-Document Conversion : ScanSoft enables Productivity Without Boundaries through its industry-leading desktop applications, developer toolkits and integrated technologies.

e-Document Management-PaperPort : Scansoft provides speech and imaging solutions that help facilitate information exchange within and between the world’s leading companies and their customers.

e-Document Transfer : Vio provides composition, proofing, preflight and delivery systems for advertising and other media.

eCopy : The eCopy solution enables you to extend the capabilities of a digital copier or scanner to be a bridge between paper and digital workflows, seamlessly integrating with other critical business applications. With eCopy, businesses can transform full-color or black & white paper documents into electronic images that are easily shared and distributed utilizing network and business applications.

eCTD Specifications : While the table of contents is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. This group has developed and begun to implement the eCTD across the ICH partner and observer regions.

eCTD-FDA : Electronic Technical Document

eCTD-Global submit : GlobalSubmit offers a variety of electronic Common Technical Document (eCTD) services

Electronic Marketing Solutions : Affinity Partners works with a provider of cost effective e-marketing solutions. They develop web-based solutions that leverage their strategy, creative and technology expertise and insights to deliver measurable value for clients in "Internet-time".

Electronic patient-reported outcomes (ePRO) : PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in clinical trials around the world and a rapidly growing organization. With PHT, biopharmaceutical and medical device companies get better data, more data, and make faster decisions - resulting in successful trials.

Electronic Submissions through the FDA ESTRI GATEWAY : The Food and Drug Administration is aggressively moving towards an electronic regulatory submissions environment.

Enterprise Collaborations : Enables enterprise collaboration with partners and suppliers in a secure online environment with less up-front investment. is a hosted, Web-based workspace that can be up and running in minutes, capable of being quickly tailored for a specific project, process, or business initiative.

Enterprise Document in High Tech : Documentum provides enterprise content management solutions as part of EMC Corporation's information lifecycle management (ILM) strategy. With a single platform, Documentum enables people to collaboratively create, manage, deliver, and archive the content that drives business operations – from documents and discussions to e-mail, Web pages, records, and rich media.

EudraVigilance - Mandatory e-reporting essentials : EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).

FDA’s GATEWAY : Electronic Submissions information.

i4i SPL Authoring : Collaborative Content for the Regulatory Process. Collaborative Authoring, Document Management and Publishing Solutions to support your global regulatory compliance requirements.

ICH Electronic Standards : Due to the information technology (IT) nature of the topic, some of the activities of the EWG result in Recommendations. These Recommendations do not undergo the formal ICH step process to allow flexible change as both science, and technologies evolve. They are agreed in the EWG, signed by all parties of the EWG, and are approved and signed off by the ICH Steering Committee within the M2 Recommendation Notebook.

ICH Multidisciplinary Guidelines : Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

Integrated Summaries of Safety and Effectiveness : The CTD summary sections in Module 2 are not the correct location for the integrated summaries of safety and effectiveness (ISS/ISE) required by 21 CFR 314.50

Lorenz-DocuBridge : Ease-of-use and fast adoption of changes to regulatory requirements: docuBridge® is the most comprehensive submission management solution on the market. The system is designed to operate in high volume environments, allowing for compilation and publishing to both paper and electronic submission formats.

MedXview : MedXview,Inc. is a global provider of regulatory software solutions and related services for the life sciences industry. MedXview’s software and service offerings help ensure clients meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time.

Mission 3 : Mission3 delivers integrated software solutions for small to mid-sized Life Sciences companies.

OmniPage Pro : OmniPage Professional 16 allows business professionals to achieve new levels of productivity by eliminating the manual reproduction of documents. Precision OCR analysis, layout detection, Logical Form Recognition™ (LFR) technology, and advanced security features quickly turn office documents and forms into over 30 different PC applications for editing, searching and sharing.

Pharmacovigilance Software- Veterinary Medicine : PV Works (Vet): Pharmacovigilance Software for adverse events reporting of veterinary medicinal products.

Pharmacovigilance Software-Human Medicine : PV works: Pharmacovigilance software for Human medicinal product adverse events reporting.

Project Management Institute (PMI) : Vital and forward thinking – focused on the needs of project management professionals worldwide; that’s the Project Management Institute of today.

Smeadlinks Express : Electronic file management for the Filing Room. Smeadlink Express File Room puts an end to missing files and enables records managers to greatly improve service to internal customers by providing instant access to file locations, usage, status, and user requests.