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Quality Assurance
Nextvel specializes in providing a comprehensive suite of Quality Assurance (QA) services aimed at ensuring compliance with regulatory standards and optimizing operational efficiency spanning diverse products and therapeutics, including gene therapy, cell therapy, medical devices, vaccines, and more.
Our QA and Auditing services include:
GxP Audits
GMP (Good Manufacturing Practice) Audits: These audits focus on ensuring that the manufacturing processes and environments meet regulatory standards to ensure product quality and safety.
GLP (Good Laboratory Practice) Audits: Specifically aimed at pre-clinical Contract Research Organizations (CROs) and laboratories associated with BA-BE sites
GCP (Good Clinical Practice) Audits: Ensuring that the clinical trials are conducted ethically and according to regulatory guidelines.
GCLP (Good Clinical Laboratory Practice) Audits: Ensuring that laboratories involved in clinical research produce reliable and valid data with integrity.
Gap Analysis
Analyzing the current state of an organization to identify gaps in compliance with regulatory requirements and industry best practices. Nextvel provides actionable recommendations for improvement to propel you toward compliance.
System Audits
We perform System audits that encompass the following:
TMF (Trial Master File) Audits: Ensuring completeness, accuracy, and regulatory compliance of trial documentation.
Clinical Study Report Audits: Reviewing the final report of clinical trials for accuracy and compliance.
Site Audits (Clinical Trial and Project-specific): Evaluating trial sites for adherence to protocols and regulatory standards.
Sponsor / CRO Audits: Audits of sponsors and CROs (Contract Research Organizations) for compliance with regulatory requirements.
Clinical Database Audit: Ensuring accuracy, reliability, and security of clinical trial data and the database used to manage trial data.
QMS (Quality Management System) Audits: Evaluating the effectiveness of the QMS in meeting regulatory requirements and improving operational reliability.
Computerized Systems Validation: We can develop validation plans for systems within your organization to ensure that the systems used in your processes are legal and safe to use.
Vendor Audits
Audits of third-party vendors such as Bioavailability/Bioequivalence (BA/BE) CROs, Central Labs, IP (Investigational Product) depots, and Database providers to ensure compliance with contractual and regulatory obligations
Due Diligence Audits
Evaluating regulatory compliance and operational risks associated with your products and devising risk management strategies to navigate the compliance landscape successfully.
Our due diligence audits focus on supporting our customers with any observations cited that would help them taking informed decisions on asset acquisitions, making investments etc.
Quality Management Systems (QMS)
We assist our clients in developing and implementing robust QMS tailored to their business operations to ensure consistent quality and compliance with regulatory requirements.
Overall, we at Nextvel focus on enhancing compliance and operational effectiveness across a wide range of regulatory requirements and industry standards. Our services are designed to support clients in maintaining high-quality standards in their products and operations, ensuring smooth operations within regulatory boundaries.