Pharma Business review is using cookies

ContinueLearn More
Close

ENNOV

Medical Device and Drug Development Compliance Specialists

Logo

ENNOV

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.

Locations:

Ennov Solutions Inc.
PO Box 4974
Manchester NH 03108-4974
Tel: 508.809.9799
Toll Free (US): 800.376.7660
Email: contact@ennov.com
URL: www.ennov.com

Ennov SA
254 rue du Fbg St Martin
75010 PARIS
France
Tel: +33 1 40 38 81 38
Email: contact@ennov.com
URL: www.ennov.com

Clinsight
11 rue Aristide Briand
33155 CENON Cedex
France
Tel: +33 5 56 40 77 45
Email: contact@ennov.com
URL: www.ennov.com

Certification

Does your company aim to achieve quality certification or is it already ISO certified? Computerizing you quality system will help you achieve this goal by helping your organization be more cost-effective and shortening processes making them more accurate. Ennov5 is the solution you need. A quality certification provides unquestionable advantages when competition is fierce. Because…

21CFR part 11

Ennov5 21CFR part 11 module is especially valuable for companies who wish to sell products on the US market that have an impact on the health of consumers and patients. They have to obtain an authorization issued by the FDA (Food and Drug Administration) after proving full compliance with 21CFR part 11 regulatory requirements. FDA…

Document Management – Life Cycle Management

Expectations Implementing an Electronic Document Management System (EDMS) is now a basic requirement for most companies, as a result of the growing need to manage and share valuable information as part of daily working processes. The most current needs to be addressed by an EDMS are the following: Management of large volumes of documents and…

Dossier (Regulatory Affairs Submission)

Dossier helps you create, assemble, update and publish a composite document(s) from various individual document sources and formats. A compound document is resulting from a dynamic merge and assembly of elementary documents monitored by a structuring and publishing agent (the Dossier module). Elementary documents might be of heterogeneous types and formats. They should be managed…

Pharmacovigilance

Since Pharmacovigilance origination in the early 1960s, the focus has not wavered in its efforts to make sure drugs and drug manufacturers take every precaution to make sure new medicines are safe and secure and produce the results intended without harmful effects to patients. Developments in scientific research and treatment has vastly increased the complexity…

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

SOP Controlling your SOPs procedures aims at improving final product quality, ensuring people and installations safety, reducing costs and timely delivery. To achieve such a goal in a cost-effective way, Ennov provides an all-in-one solution to manage quality documents, improve procedure awareness, streamline appropriate workflows and finally track deviations in order to continuously improve your…
Quick Contact ENNOV
Quick Contact ENNOV


Quick Contact ENNOV
Quick Contact ENNOV
Quick Contact ENNOV


Contact ENNOV

Optional Data

Almost there, complete this form and hit the submit button to complete your registration.

Confirmation

Finally, complete a quick security check and confirm terms and conditions:

Quick Contact ENNOV