DIA Reception: Accelerating Submission Lifecycles...


Meet with experts in the e-submissions arena, LORENZ, MasterControl, Sage Submissions, and
e-Submissions Solutions during DIA's 8th Annual Electronic Submissions Conference for a complimentary cocktail reception, Wednesday, November 18th. The reception will be held at Busters Beach House, Seaport Village, San Diego, CA from 6:30 - 8:30 PM.

 

Register Now: https://www.mastercontrolcustomers.com/shop/product/corrective-and-preventive-action-skills-for-regulated-industry-professionals-1225.cfm?wonpohs=ECSSLLKKESDS

Making Your Submissions Management Processes Faster & Easier!

Learn how using a robust document management system integrated with a world-class electronic submissions management system can accelerate your submissions, all while ensuring compliance with regulatory documentation and submissions guidelines. Find out how these software solutions work together to make e-submissions faster and easier!

 

Location

Drinks and appetizers will be served. Busters Beach House is just a short walk from the Westin San Diego. Attendees must register in advance.

   
Buster's Beach House
807 West Harbor Drive (Seaport Village)
San Diego, CA
Time: 6:30 - 8:30 p.m.

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ABOUT THE SPONSORS

LORENZ Life Sciences
Yaprak Eisinger
(914) 310-0097
yeisinger@lorenz.cc
http://www.lorenz.cc/
 


LORENZ Life Sciences Group is the leading innovator for e-Regulatory Affairs solutions globally. As the most focused and established solution in this field, LORENZ' software is responsible for more electronic submissions globally than any other solution on the market.

LORENZ Life Sciences Group is a member of the LORENZ Group, which started as an independent provider of electronic system solutions in 1975. The LORENZ Group has evolved to cover a number of specialized high-tech market segments and has built bridges between conventional thinking and industry-specific innovations. The multitude of specialized segments has allowed the group to transfer technologies into other areas and thereby identify new business benefits.
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MasterControl Inc.
800-825-9117
Michael Bothe
mbothe@mastercontrol.com
www.mastercontrol.com

 


MasterConrol Inc. produces software solutions that enable regulated companies to get products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl also helps those regulated companies easily manage documents that will be submitted to regulatory agencies as part of marketing applications. Partnering with vendors of regulatory submission publishing tools further extend that functionality to ease one of the pains of the submission publishing, that is, securely moving documents from the repository to the publishing tool. Other integrated MasterControl solutions include training management, quality management, product lifecycle management, audit management, bill of materials, supplier management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 1256 325949 (Europe); or 03-6801-6147 (Japan).

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Sage Submissions LLC

(866) 434-6519

Lee Knoch
Director of Sales and Marketing
info@SageSubmissions.com

 

 


Sage Submissions, L.L.C. provides Sage Templates software for use with Microsoft Word to enable authors to create the content of development stage and marketing authorization documents for submission to US FDA and EU EMEA regulatory authorities. Sage Templates support the authoring of IND, NDA, BLA, MAA, CTA-IMPD and QbR submission documents. Sage Submissions provides training, consulting, and configuration services to assist life sciences companies making the transition from paper submission to the electronic Common Technical Document (eCTD) format at all phases of drug and biologic product development.
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e-SubmissionsSolutions.com

Antoinette Azevedo
President and CEO
Toll Free: (877) 434-1030
Mobile: (619) 787-1514
aazevedo@e-submissionsSolutions.com
www.e-submissionssolutions.com

 

 


e-SubmissionsSolutions.com provides consulting services to life sciences companies making the transition to the eCTD format. They provide eCTD Readiness Assessment and Gap Analysis to assess the current capability and provide a roadmap for implementing systems and processes to achieve the eCTD vision. This includes selection and implementation of eCTD and electronic document management systems, validation services, eCTD training and staff augmentation.

e-SubmissionsSolutions.com implements MasterControl Documents systems to manage the initiation, workflow and approval and publishing of eCTD submissions. e-SubmissionsSolutions.com provides consulting, training, implementation and validation services to MasterControl customers who wish to implement eCTD document management or who wish to extend their current systems to manage eCTD documents.


Register Now: https://www.mastercontrolcustomers.com/shop/product/corrective-and-preventive-action-skills-for-regulated-industry-professionals-1225.cfm?wonpohs=ECSSLLKKESDS