eCTD & eDMS Submissions Software, Regulatory Pharmaceutical Electronic Document Management Syste

Web Name: eCTD & eDMS Submissions Software, Regulatory Pharmaceutical Electronic Document Management Syste

WebSite: http://www.pharmaready.com

ID:261453

Keywords:

Submissions,Software,Regulatory,eCTD

Description:


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Navitas Life Sciences’ pharmaREADY is a fully integrated, regulatory compliant, web-based suite comprised of Document Management, Training Records Management, Structured Product Labelling, and eCTD Publishing Solutions. pharmaREADY simplifies the complex process of creating, viewing, and managing submissions – electronic, NeeS or paper.

pharmaREADY® is the low cost (lowest total cost of ownership in the industry) cloud or on premise regulatory suite. Intuitive and easy to use, installation can be achieved in 4-5 days. During implementation our team of expert navigators will provide training and walk you through your first submission; ongoing 24/7 technical support is also provided.

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pharmaREADY Products
Navitas Life Sciences pharmaREADY is a web-based electronic Document Management, SPL, and eSubmission Publishing Solution suite suitable for both emerging and medium sized biopharmaceutical and medical device organizations.

Regulatory Services
The Navitas Life Sciences pharmaREADY eSubmissions team has been providing expertise in preparing regulatory submissions throughout the world for over 20 years.

pharmaREADY Hosted in the Cloud
With tighter capital expenditures and continual pressure to cut costs, Life Science companies are embracing productivity tools in a “software as a service” model.

Global Compliance
Navitas Life Sciences pharmaREADY customers can be assured they will achieve…


News & Events

29May2019

8th Annual Global Pharma Regulatory Summit

Navitas Life Sciences will be present at the 8th annual Global Pharma Regulatory Summit from 29 -31 May 2019 at The Lalit Mumbai, India...

13Feb2019

Navitas Life Sciences announces acquisition of DataCeutics Inc to augment global Clinical Data Science Services

Navitas Life Sciences, a TAKE Solutions Enterprise today announced that it will be acquiring Life Sciences services player, DataCeutics in North America...

Clients Speak about pharmaREADY

Peter Steiger, Ph.D., CEO -Synarc

“I have been monitoring the progress of our pharmaREADY project very closely and have been able to personally work with your system. We have been very happy with the progress and have appreciated the attention you have given Synarc as a customer. We are looking forward to expanding our relationship and to using your software in other areas of the company.”

David Gardner, President - ProviderLink

“Our investigation found pharmaREADY to be the most affordable document management solution on the market today. And the fact that pharmaREADY meets the Federal regulations mandating Part 11, cGMP, and HIPAA compliance was key in our decision to select Navitas.”

CEO of US based Pharma Company

“The software (pharmaREADY) has been an excellent investment for our company’s FDA electronic filings. We found working with Navitas a pleasure from installation and validation through ongoing support. We will fully realize return on our investment with their user-friendly product, ongoing support, and periodic training.”

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Industry Article

eCTD Technical Conformance Guide

FDA has published a Technical Specification Document, eCTD TECHNICAL CONFORMANCE GUIDE on its eCTD Web Page (added on 10/05/2015)...



Four Reasons Drugs are Expensive – Of Which Two are False

From Matthew Harper at Forbes...





Thai eCTD FAQ - In 2017 eCTD submission will be mandate for all submission.

eCTD Submission will be mandate for New Chemical Entity, New Drug, New Biological, Biological and optional for Generic and New Generic...

Some of our Clients

USEuropeAPACCANADAANZME
Copyright © 2022 pharmaREADYPrivacy Policy | Terms

What We Do

Products
pharmaREADY Product SuiteDocument Management System electronic Common Technical Document SystemStructured Product Label ManagementTraining Records Management SystemPaper Submissions Module
Services
US FDA ServicesEuropean - EMEA ServicesHealth Canada ServicesTrial Master File Management ServicesValidation Services
Hosted in the Cloud
pharmaREADY Hosted in the Cloud
Global Compliance

About pharmaREADY

About pharmaREADYLeadershipPartnersNewsEventsIndustry Article
07May2019

Navitas Life Sciences announces acquisition of DataCeutics Inc to augment...

Navitas Life Sciences, a TAKE Solutions Enterprise today announced that it will be acquiring Life Sciences services...

09Jun2017

Life Sciences expert Navitas augments end-to-end capabilities

Navitas, a technology-led Life Sciences services provider across Clinical, Regulatory and Safety, announced that it would be...

02Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures ingredients for global...

05Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the...

12Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules...

16Oct2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ...

HomeAbout UsAbout pharmaREADYLeadershipPartnersNewsEventsIndustry ArticleContact Us

TAGS:Submissions Software Regulatory eCTD

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