Nexage Technologies USA Inc.

Life Sciences: NexAge Life Sciences (NLS) is a division of NexAge Technologies USA that specializes in consulting, project management and staffing services to the Life Sciences industry all across the US. The services provided by NLS include: Regulatory compliance, IT Audits, Validation services and Quality Assurance to FDA regulated industries including pharmaceutical, biotechnology & medical devices.

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The more complicated State and Federal regulations become, the more challenging it becomes for organizations in the Life Science and other regulated industries to utilize computer systems in a fully compliant manner. These organizations have to plan, implement and document all validation activities not just from the standpoint of meeting critical compliance requirements but also to enhance security, reliability, safety, efficiency and profitability.
This situation creates several challenges such as:

Identifying people with the right skill and experience and the related resources to stay up-to-date with rapidly changing regulatory developments and to be constantly prepared for an FDA audit/inspection.
Recruitment, training, development and deployment of in-house personnel to meet regulatory compliance requirements are always a costly proposition.
Meeting consumer demand for high quality standards at affordable prices under difficult economic environment.
Balancing dual priorities of equal importance: the ongoing regulatory changes in the industry as well as the implementation of new processes and technologies.

By contrast, a partnership with NexAge Life Sciences (NLS) team which specializes in compliance and validation allows Life Sciences organizations to meet the cyclical validation requirements while freeing up valuable internal resources to focus on core business functions. NLS service offerings include:

Regulatory Compliance through Computer Systems and Equipment Validation Services
Validation Strategic Planning
Creation of Corporate Policies and Standard Operating Procedures for Compliance
Risk Based - Information Technology Audits
FDA Form 483 and Warning Letter Analysis, Corrective Actions and Implementation
Specialized Validation Training and Guidance
Strategic Project Staffing

Why Partner with NLS?

Direct access to subject matter experts who have deep and relevant experience and current knowledge across a broad spectrum of validation and compliance practices
Predictable costs through the implementation of clear roles and competence frameworks
Elimination of validation bottlenecks, by taking it off the critical path of your projects, leading to faster project completion
Access to independent auditing by a group of highly skilled compliance professionals.
Ongoing collaborative review of validation procedures, securing timely opportunities to implement a risk-based validation methodology.

What value does NLS bring to the table? The most critical value addition we provide is providing cost-effective solutions and the deep understanding of the various challenges that cGxP regulated industry face. Through our well thought through methodologies, we bring years of relevant experience. As a committed team of validation and regulatory compliance specialists, we have our clients covered in most aspects of compliance and validation. We are committed to deliver the high level of compliance required by Life Sciences organizations. Our goal is simple: earn the trust of our clients by consistently exceed expectations. Our industry knowledge, integrity, excellence in execution, competitive pricing models and quick results are distinct advantages that makes our value proposition compelling.

To learn more please contact us to schedule a complimentary meeting with our compliance specialists. We invite you to partner with us.

NexAge Life Sciences
75 Lincoln Highway Iselin, NJ 08830, USA
PH: 1-732-494-4944
FAX: 1-732-494-4555
Email: info@nexageusa.com
www.nexageusa.com

Healthcare: Healthcare is the most recent area of strategic focus for NexAge Technologies USA. On February 17, 2009 President Obama signed into law The American Recovery and Reinvestment Act of 2009, providing a tremendous opportunity to improve the quality, safety, cost-effectiveness of healthcare in the United States. The law provides $19.2 billion in health information technology funding to ensure widespread adoption and use of interoperable healthcare IT systems such as the Electronic Medical/Health Records (EMR/ EHR). Our business strategy is to leverage our relationships network in the healthcare industry to capitalize on this unique opportunity in healthcare. Our goal is to develop a strong presence in the Healthcare market in the US by providing innovative software, connectivity and information solutions that empower physicians, hospitals, clinics and other healthcare providers to deliver best-in-class patient safety, clinical outcomes and financial results. The end result we aim to achieve is to help clients reduce paperwork and eliminate silos thereby driving productivity and reducing cost. We are in the process of reviewing a wide range of the most cost effective solutions that uses the Service-Oriented Architecture (SOA) with the latest advancements in secure, web-based platform technology that ensures safe, reliable data integrity and HIPAA privacy and security compliance – without the need to purchase expensive computer systems, software, and maintenance contracts. Some of the key health care applications we are currently investigating are:

Electronic Medical Records (EMR)
Practice Management Systems
Billing and Revenue Cycle Management
Picture Archiving and Communication Systems (PACS)
Electronic Prescribing (eRX)
Document Management Systems
Care Management
Training and Support Services

In collaboration with our strategic partners, we are in the process of working out the details of our strategy and execution. Please contact us at info@nexageusa.com for more information.