Regulatory Submissions, Information, and Document Management - DIA Global

Digital Exhibitor Directory

Regulatory Submissions, Information, and Document Management

February 6-8, 2017 | North Bethesda, MD Bethesda North Marriott Hotel and Conference Center t

ACUTA LLC

225 Cedar Hill Street, Suite 200 Marlborough, MA 01752

Contact Person: Phone: Email: Website: Twitter Handle: LinkedIn:

Donald Palmer | Director, Product Strategy & Regulatory Informatics +1.240.457.0644 donald.p@ @AcutaLLC pany-beta/2934853

Our mission is to be the partner of choice for the life sciences and related industries by helping you to collect, manage and share regulatory information through innovative, reliable and cost-effective technical and software solutions.

ARIM is built around a very clear and well-designed workflow that addresses a wide range of requirements without burdening end users with unnecessary complexity.

A proven and affordable cloud-based system enables rapid implementation and deployment, and is backed by responsive and professional training and support.

800 Enterprise Road, Suite 200 Horsham, PA 19044 USA



Regulatory Submissions, Information, and Document Management Forum

DIGITAL EXHIBITOR DIRECTORY

AMPLEXOR Life Sciences

101 Eisenhower Parkway Roseland, NJ 07068

Contact Person: Phone: Email: Website: Twitter Handle: Facebook: LinkedIn:

Eric Haase | Director Strategic Accounts +1.585.880.2590 eric.haase@ lifesciences @AMPLEXOR AmplexorInternational pany/amplexor-international

AMPLEXOR Life Sciences helps pharmaceutical, medical device and biotechnology organizations launch products and break new markets quickly. Its solutions and services globally expedite the creation and delivery of consistent, compliant, and high-quality global content and data convergence ? both physical and digital. Its services include technology consultancy, implementation and management services, as well as technical writing, medical translation, and linguistic validation services.

AMPLEXOR is the market leader in medicinal product information. Its AMPLEXOR Life Sciences SuiteTM is the only next-generation solution available that is Integral by Design, Modular by ImplementationTM, that provides a single, authoritative source of "product truth" across an organization.

The AMPLEXOR Life Sciences SuiteTM is a unique and innovative Integral by Design, Modular by ImplementationTM solution which is fully and easily configurable.

This integral approach is the DNA of the solution, a true holistic solution, unlike integrating multiple components into an imperfect whole. With our integral methodology, life sciences organizations can benefit from one universal object model, one single user interface philosophy with process specific applications and an integral Quality Management System, to manage product data holistically.

With the combination of data model and process-centric and role-based workspaces, AMPLEXOR Life Sciences? unique user interface enables a user-friendly way to manage data complexity. Combined with other powerful functionalities such as Change Control to manage the entity lifecycle, it offers the next generation of applications in this area.

LIFE SCIENCES. COMPLIANCE. PASSION.

ON-P DEVICES

LOUD ON DESK

Featuring the Next Generation RIM, including DMS, functional IDMP and Submission Management, with both integral and modular architecture.

REMISES | IN C

CONTACT US: lifesciences | sales@

TOP | ON MOBILE

800 Enterprise Road, Suite 200 Horsham, PA 19044 USA



Regulatory Submissions, Information, and Document Management Forum

DIGITAL EXHIBITOR DIRECTORY

arivis

2198 East Camelback Road, Suite 205 Phoenix, AZ 85016

Contact Person: Phone: Email: Website:

Gerard J Bradley | Director +1.480.269.8124 gerard.bradley@

arivis award winning Clireo suite (eDMS, eQMS, eTMF, eCTD, and eMPM) consists of integrated modules delivered via the Microsoft Azure cloud. We are committed to delivering quality software that is easy to implement and use. Our Professional Services Group of industry experts provides unparalleled support for all FDA electronic submissions.

800 Enterprise Road, Suite 200 Horsham, PA 19044 USA



Regulatory Submissions, Information, and Document Management Forum

DIGITAL EXHIBITOR DIRECTORY

Cardinal Health Regulatory Sciences

7400 West 110th Street, Suite 300 Overland Park, KS 66210

Contact Person: Phone: Email: Website: Twitter Handle:

Chris Kavlick | Director, Business Development +1.913.661.3835 Chris.Kavlick@ regulatorysciences @CardinalHealth

Cardinal Health Regulatory Sciences delivers proven regulatory consulting expertise to help you obtain global product approval and maintain filings throughout the entire product lifecycle. For 40 years, our more than 150 industry-and FDA-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to market quickly. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on research investments. Our strategies have proven successful for more than 100 New Drug Application (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA) approvals. We've provided drug development services for new drugs in all major therapeutic areas.

Cardinal Health Regulatory Sciences

Accurate. Accelerated. Approved.

For 40 years,

our team of experts has delivered proven regulatory consulting expertise to help you obtain global product approval and maintain filings throughout the entire product lifecycle.

? 2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No.1SS17-623608 (01/2017)

Booth 202

Our regulatory experts understand that each product is unique. Come meet us to learn how we can create opportunities for your product development program.

Learn more at: regulatorysciences Email us at: regulatoryscience@

1SS17-6623608 - SS_Reg Sci_Dia promo-wkg-v1.indd 1

1/18/17 1:23 PM

800 Enterprise Road, Suite 200 Horsham, PA 19044 USA



Regulatory Submissions, Information, and Document Management Forum

DIGITAL EXHIBITOR DIRECTORY

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