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:
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:
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.
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.
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.
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.
Project Management Services
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:
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)