The PharmaReady Product Suite includes a robust set of fully integrated web-based applications.
PharmaReady Suite provides seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions. PharmaReady Suite is also available à la carte with individual products. More...
PharmaReady DMS is a web-based Document Management System that automates and seamlessly manages your document control process to ensure compliance with international regulatory authorities like FDA (USA), EMEA (European Union), Health Canada (Canada), TGA (Australia), and HSA (Singapore). More...
PharmaReady eCTD is designed specifically for the management of submissions using the ICH eCTD standards, technologies and methodologies. More....
PharmaReady SPL is an industry-proven solution, suitable for all sizes of pharmaceutical organizations that are required to create SPL XML files including the new SPL R4 mandate from FDA. More...
PharmaReady TRMS is designed specifically for management of training related to SOPs, Work Instructions, and other Specifications documents within business areas regulated by global regulatory agencies. More...
While eCTD is the way forward, majority of the developed and developing nations still support paper submissions as opposed to electronic submissions until they are equipped to fully accommodate electronic submissions. More...
PharmaReady eSubmissions team provides expertise in preparing FDA submissions (NDA, IND, ANDA, BLA, DMF) for sponsor companies in eCTD format. PharmaReady SPL Conversion team has extensive experience in converting and creating thousands of labeling XML files compliant with SPL guidelines and accepted by FDA. More....
PharmaReady eSubmissions team carry extensive experience in providing eSubmissions consulting for any submission made in the context of a Centralized Application Procedure and the subsequent maintenance of the lifecycle of the application. More....
PharmaReady eSubmissions team can handhold the sponsor through the eCTD submissions process for NDS, ANDS, SNDS, SANDS applications using a step-by-step approach towards a successful eCTD submissions acceptance with Health Canada. More....
PharmaReady TMF Consulting team can provide strategic planning and support in implementing an electronic centralized method of compiling, storing and archiving the TMF documents. More....
PharmaReady Validation Consulting team can provide experienced QA Specialists performing Quality Assurance services tailored to your needs at low cost in a time-efficient manner.PharmaReady Validation Consulting division carries over 20 years of experience, a proven success rate, and many satisfied global customers. More....
With a tougher economy and tighter capital expenditures, Pharmaceutical and Life Sciences companies of all sizes are faced with the challenge of reducing their total cost of submission. PharmaReady's secure and scalable architecture offers a perfect low-cost alternative to the conventional upfront purchase of an eCTD / SPL or DMS platform license.
In addition to the traditional “on-site” implementations of PharmaReady, all PharmaReady software solutions are also available via our secure, remotely hosted data center. We call this “PharmaReady On-Demand™”. To ensure maximum flexibility for our customers, we offer two creative hosted licensing models.
PharmaReady On-Demand™ Hosted Licensing Options:1. On-Demand Term™: Our PharmaReady On-Demand Term licensing requires an annual hosting agreement. Annual Agreements can be tailored for just a few users all the way up to unlimited users, for the term of the hosting contract. To assist with long-term budget planning, multi-year hosting agreements are available as well. In addition, monthly, quarterly, or yearly payment plans can be structured to meet the specific budgetary needs of each client.
2. On-Demand Submissions™: Our PharmaReady On-Demand submission-based licensing agreements can be tailored for the small biotech that is planning just one or two submission all the way up to the large CRO that requires many submissions on behalf of its global customer base. On-Demand Submissions™ also offers monthly, quarterly, or yearly payment plans tailored to meet the unique budgetary requirements of each organization.
PharmaReady On-Demand™ is a secure hosted eDMS, eCTD and SPL solution. With PharmaReady On-Demand there are minimal start-up costs with nothing to install on your site. No customer hardware or software is required. If overwhelming software license fees, infrastructure, and training are keeping your organization from becoming FDA compliant, PharmaReady On-Demand now eliminates your roadblocks to compliance. Within a week you'll be using the features and capabilities that make PharmaReady the global leader in regulatory compliant Document Management Solutions. More...
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Wanbury Limited signs up for TAKE Solutions’ PharmaReady SPL solution suite
TAKE Solutions’ signs up Novel Therapeutics
TAKE Solutions consolidates leadership in the Indian Pharma Solutions market
One Day Workshop: Clinical – Regulatory – Safety August 21, 2010 Mumbai, India
DIA India: 5th Annual Conference on Drug Discovery and Clinical Development Meeting the Challenges of Next Generation R&D: Enhancing Efficiency, Effectiveness and Innovation October 24-26, 2010 Bangalore, India
Dabur Limited
Health Care, Personal Care/Food Products Company
Conatus Pharmaceuticals
Biopharmaceutical Company
Wake Forest University Baptist Medical Center
Largest U.S. public clinical research institution