What we do

Regulatory Affairs and Compliance Solutions:

The more complicated State and Federal regulations become, the more challenging it becomes for Life Sciences companies to adhere to the compliance while keeping the costs in check. GxP regulated industries have to plan, implement and document all validation activities not just from the standpoint of meeting critical compliance requirements, but also to enhance security, efficiency and profitability. We provide services that help companies achieve gold standard in compliance, improve quality and bring in operations efficiencies across the entire product development lifecycle. We specialize in GxP Compliance, Quality Assurance and Quality Systems. Our services increase productivity and reduce bottlenecks to drive business performance to new highs. Some of the challenges that GxP companies experience are:

  • 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.
  • 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, with the implementation of new processes and technologies that are also compliant.

Computer Systems Validation

For most Life Sciences organizations, meeting the requirements established for the Compliance and Validation of computer systems is not a task that can be easily handled in-house. Validation provides the Life sciences industry many benefits, including:

  • Assurance of safe and quality products
  • Reliable equipment and systems
  • Processes that can be replicated
  • Long term rewards associated with Quality Systems and Procedures

With NEXAGE as a strategic partner, Life Sciencescompanies have an experienced, single-source provider delivering a comprehensive and cost-effective suite of validation services and technology solutions to help Life Sciences Companies keep regulatory operations fully compliant. Our validation teams keep abreast of current practices through our liaison with international clients, updates from regulatory authorities, participation in industry conferences, partnering with vendors and strategic involvement with the GAMP forum.

Quality Review

For life sciences companies it is vital to form a strong partnership with a reputable remediation company to gain confidence of regulatory authorities, stakeholders and consumers. NEXAGE advisory services division specializes in remediation and regulatory compliance consulting.

  • SMEs collaborate with FDA-appointed overseers and client leadership to help avoid and/or remediate issues related to critical events such as product recalls, warning letters and court-ordered injunctions.
  • NEXAGE’s cost effective and flexible consultative model provide SMEs, expertise, resources, and project management services to clients during any phase of a remediation engagement — either by staff augmentation or by planning and project execution
  • We perform quality systems implementation and offer risk reduction services including audits and FDA drill.

Vendor Audits

FDA and other regulatory agencies (e.g., EMEA, MHLW and MHRA,) have increased focus on quality issues throughout the supply chain and drug manufacturing process. Therefore, it is critical for life sciences companies to emphasis on vendor and supplier audits to evaluate the vendor’s, documentations, quality management systems, products, processes and practices.

  • Vendor/Supplier audits are conducted by a team of quality compliance professionals
  • We provide certified auditors who are knowledgeable and industry experienced.
  • Provide detailed audit report with all audit observations and findings
  • We provide assistance in establishing vendor/supplier qualification program and maintaining approved vendors / suppliers list
  • We perform supplier audits as part of for-cause investigations or on a scheduled basis

CSV Governance

The regulatory authorities are encouraging the industry to adopt a risk-based approach to computerized system validation (CSV) and compliance with Electronic Record/Electronic Signature (ER/ES) regulations. A harmonized and consistent risk-based CSV is an effective way to optimize the ROI allocated to corporate compliance programs. Furthermore, It should add value to the business by contributing to control and quality and at the same time address applicable regulations and business needs.

  • We establish a fully matured set of CSV standards which incorporates an integrated risk analysis and is aligned across business areas and regulations.
  • We offer a harmonized CSV governance structure which integrates quality and compliance management system that is not only compliant but lean.
  • We provide guidance, direction and establish standards for deliverables and help govern overall processes.
  • We provide appropriate training and coaching to IT professional and users to follow a consistent approach.
  • CSV metrics and measurements are used to monitor and drive improvement. The metrics reflect standardized definitions and meaningful measurements of quality and compliance.

Project Management Services

  • NEXAGE has developed alliances with key clinical system providers and has proven track record in delivering results –on budget and on time
  • We facilitate and manage projects on stand-alone basis or as part of an “full service” integrated solution
  • We offer customized services based on our client’s specific needs
  • NEXAGE team members are SMEs in the applications and technologies involved in the project and understand each client’s business processes and compliance needs
  • We work on specific tasks against the agreed upon budget.
  • NEXAGE team members are available onsite as needed
  • Clients receive weekly status reports

Strategic Pharma Consulting and Corporate Training Services

Recruitment, training, development and deployment of in-house personnel to meet regulatory compliance requirement is always a costly proposition. By contrast, a partnership with an organization that 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.NEXAGE provides clients with efficient and effective assess to most vital and critical resource-human talent. Our staffing services encompass specific areas of Clinical Research & Development, including Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical IT, and much more. We know the clinical research business, and are fully aware that it needs a cohesive team to move your product to market efficiently and cost effectively. We attract, recruit, grow and retain talent at global level by providing rewarding careers to fully utilize their knowledge and skills and also a platform to advance their skills and grow.

Our strategic consulting and training services focus n the following areas:

  • Regulatory affairs
  • Computer system validation analyst: Equipment validation, IQ, OQ, PQ writers, Infrastructure Qualification engineer, Technical Writers
  • Pharmacovigilance: Quality Specialists, Safety Specialist, Project Managers
  • Biometrics/Clinical IT: SAS Programmer: Data Analyst, Business Analyst, Directors and Project managers

Life Sciences Implementation Methodology:

In the area of Computer Systems Validation (CSV) for the life sciences and pharmaceutical industry clients where quality and regulatory compliance throughout the software and systems development lifecycle is of critical importance, NEXAGE has developed a proprietary process platform called Risk-based Optimum Validation Methodology (ROVM), based on the best practices and the insights that we have gained over the years servicing major pharmaceutical clients. FDA Regulations as well as ICH Q9 has made reference to an expectation that risk management approaches would serve as a basis for Quality and Validation activities. ROVM centers on the FDA and GAMP 4/5 promoted risk based approach.

Risk-based Optimum-level Validation Methodology (ROVM)

The ROVM helpsclients

  • 1. Utilize Life resources optimally
  • 2. Operate in a structured manner
  • 3. Gain regulatory compliance and business confidence
  • 4. Implement a consistent approach to validation
  • 5. Periodically assess the validation state of systems.