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Life Sciences:

NexAge Life Sciences (NLS) is a division of NexAge Technologies USA that specializes in consulting 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.

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
  • Independent Quality Management and Testing Automation
  • Strategic Project Consulting
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.

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