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Medical Device and Drug Development Compliance Specialists



ENNOV INC. (Ennov) provides Ennov5 "Business Suite Solutions" to enable companies to obtain and maintain regulatory compliance while focusing their attention on the business of maximizing profitability by leveraging computing technology.

Our 300+ global customers have come to depend on Ennov and our "Out of the Box" integrated solutions to provide the highest level of quality and reliability for managing documents, quality / business processes, regulatory dossier submissions and clinical trials. The strength of our solution is developed especially to meet the needs of life sciences and medical device companies. Ennov is innovative and keeps looking for the best ways to develop value and functionality required to meet today’s objectives with an eye towards tomorrow’s requirements.

Ennov5 Business Suites®

  • Capture System (Clinical Trials Data Management System)
  • Document Life Cycle Management including
  • BPM for QMS including (CAPA, DEV, COMPLAINTS, audits, RECALL, SOPs & training and any business process related need)
  • Dossiers (CTD, eCTD, Nees, NTA)
  • Pharmacovigilance (E2B, AEs, ICSR, PSUR, SUSAR)
  • Project Services

Ennov Capture System

Ennov Capture System provides the most robust and easy to use solution to capture data associated with clinical trials. This solution enables your data managers to have complete control of the design and definition of the data to capture without the need for expensive IT resources. Data managers can manage the entire project and be assured to have the data correctly entered, controlled, coded, queried, tested, reported, imported and exported in the proper format needed for analysis. All activities are recorded for audit trial requirements making us one of the fastest systems to deploy and validate.

Ennov5 Doc

Ennov5 Doc provides users with the ability to manage documents based on their corporate objectives. Because companies can operate autonomously between divisions, units and departments, it is increasingly important to be able to provide the proper document life cycle management based on the objectives at hand. Whether you are driving uniformity or providing a flexible engaging environment, Ennov5 is unmatched in its ability to provide true value in reducing operational costs in document life cycle management. (supports: PDF Conversion, CFR21.11)

Ennov5 Process

Ennov5 Process is a true business process management (BPM) system with a built in BPM graphical configuration tool. The design and build of your most complex business processes can be originated and applied within weeks of concept. The solution provides for application of all the safety and controls you need to insure information accuracy and integrity though its work-flow. Whether you take advantage of our library of templates or customize your own template, no solution will deploy, configure, validate and become operational faster then Ennov5 Process. (Supports full audit trail of events and CFR21.11)

Ennov5 Dossier

Ennov5 Dossier is tailored to companies needing to provide regulatory affairs dossiers in accordance to the strictest regulatory requirements. Whether you are submitting dossiers in paper or electronically, you can achieve a level of confidence when using Ennov5. Adding in the template requirements of various agencies such as NEES, FDA and others, companies find themselves expending a great deal of time, energy and expense in trying to comply. With Ennov5 you have the power to manage all your submission document needs from an easy to use solution. (Supports NTA, CTD, eCTD, Nees, Study Tagged Files)

Pharmacovigilance package

The pharmacovigilance package is an out of the box software solution for managing the lifecycle of ICSR: creation, review, approval, transmission to FDA, EMEA and National Competent authorities (E2B), follow up. Supports: PSUR, SUSAR, CIOMS, MedWatch, Cerfa, import of E2B ICSR, import adverse event from Capture System. Using integrated coding function with MedDRA and WhoDrug insures you have the right information to reduce regulatory authority rejection.

Project Services

Ennov project services team has acquired over ten years of experience in assisting global customers to gain the most competitive and reliable implementations of Ennov solutions to meet your business objectives. Executing a proven methodology to coordinate a customer’s vision with the requirements of strict regulatory guidelines, we know how to deliver the functionality and streamline process to improve operational efficiency and drive down costs. With Ennov services you can trust you have a partner who is always looking out for your best interest.


Ennov Solutions Inc.
PO Box 4974
Manchester NH 03108-4974
Tel: 508.809.9799
Toll Free (US): 800.376.7660

Ennov SA
254 rue du Fbg St Martin
75010 PARIS
Tel: +33 1 40 38 81 38

11 rue Aristide Briand
33155 CENON Cedex
Tel: +33 5 56 40 77 45


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Dossier (Regulatory Affairs Submission)

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QMS (SOP, Non-Conformance, CAPA, Audits Customer Claims)

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