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eCTD & eDMS Submissions Software, Regulatory Pharmaceutical Electronic Document Management System - pharmaREADY You are using an outdated browser. Please upgrade your browser or activate Google Chrome Frame to improve your experience. Resources | -- Support User Forum -- | Contact Us Home About US About pharmaREADY Leadership Partners News Events Industry Article Products pharmaREADY Product Suite Document Management System electronic Common Technical Document System Structured Product Label Management - SPL – R4 - Label Conversion Services Training Records Management System Paper Submissions Module Dossier Approval Information System -- Services US FDA Services European - EMEA Services Health Canada Services Trial Master File Management Services Validation Services Hosted in the Cloud Global Compliance Contact Us Home About Us About pharmaREADY Leadership Partners News Events Industry Article Contact Us The Navitas Life Sciences management has implemented the following precautionary measures in response to the COVID-19 pandemic, to protect our customers and staff Team Lead Mapping: Geo leaders and HR teams have a complete mapping of both full-time as well as contract resources to identify those in regions at risk, and will trigger precautionary and contingency backup measures for continuity of services, based on the extent of risk alert. Risk Management Plan: Geo leaders and HR teams have identified and initiated, as appropriate, approvals for staff to work from home, including the period for which such policy will be in effect. Multi-disciplinary BCP teams are continuously in touch with stakeholders, and are prepared to provide required support for both employee welfare as well as customer delivery requirements to the extent possible. Travel Schedule: Travel plans have been rearranged, and teleconferencing has been identified as the preferred channel of engagement, even for customer interactions, during this period. Separate travel advisories have been issued through respective location heads. Download the pharma READY ® brochure NOW! Download Now Navitas Life Sciences’ pharma READY 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. pharma READY ® 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. Request Demo pharma READY Products Navitas Life Sciences pharma READY 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 pharma READY eSubmissions team has been providing expertise in preparing regulatory submissions throughout the world for over 20 years. pharma READY 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 pharma READY customers can be assured they will achieve… News & Events 29 May 2019 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... 13 Feb 2019 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 pharma READY Peter Steiger, Ph.D., CEO -Synarc “I have been monitoring the progress of our pharma READY 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 pharma READY to be the most affordable document management solution on the market today. And the fact that pharma READY 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 ( pharma READY ) 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.” -- 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 US Europe APAC CANADA ANZ ME Copyright © 2020 pharmaREADY Privacy Policy | EU-US & Swiss-US Privacy Shield Policy | Terms -- What We Do Products pharmaREADY Product Suite Document Management System electronic Common Technical Document System Structured Product Label Management Training Records Management System Paper Submissions Module Dossier Approval Information System -- Services US FDA Services European - EMEA Services Health Canada Services Trial Master File Management Services Validation Services Hosted in the Cloud pharmaREADY Hosted in the Cloud Global Compliance USA - FDA Compliance European - EMA Compliance Health Canada Compliance -- About pharmaREADY About pharmaREADY Leadership Partners News Events Industry Article 07 May 2019 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... 09 Jun 2017 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... 02 Nov 2016 BioVectra chooses pharmaREADY for eCTD Solution BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures ingredients for global... 05 Oct 2016 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... 12 Jul 2016 Navitas Celebrates 100th pharmaREADY customer pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules... 16 Oct 2015 Navitas Introduces Innovative Regulatory Process Outsourcing Model The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ... Home About Us About pharmaREADY Leadership Partners News Events Industry Article Contact Us...