We combine thorough domain knowledge, in-depth industry experience, and a strong partnership approach to help you achieve compliance with global quality and regulatory standards..
At Assuregxp, we are a leading independent quality assurance organization dedicated to providing exceptional services to the Pharma and life sciences industry within the GXP domain. With our deep domain knowledge and extensive industry experience, we specialize in supporting organizations operating in the GXP environment to instil quality right from the design phase.
Our approach is holistic, encompassing a comprehensive understanding of the entire drug development lifecycle. By leveraging our expertise, we empower our clients to comprehend and opt the right compliance measures, ensuring that their products and processes meet the highest quality standards.
We are dedicated to fostering a culture of quality and excellence in the Pharma and life sciences industry.
Our team of experts possesses in-depth understanding and expertise in the GXP domain. We stay updated with the latest industry trends, regulations, and best practices to provide our clients with valuable insights and guidance.
We offer a comprehensive range of services encompassing quality assurance, compliance, risk management, and process optimization. Whether you need assistance in developing robust quality systems or streamlining your operations, we have you covered.
Navigating the complex landscape of regulations can be challenging. We assist our clients in developing and implementing customized compliance strategies that align with international standards and local regulations, ensuring seamless compliance throughout their operations.
By incorporating quality into every aspect of your organization, you can achieve improved efficiency, reduced risks, and enhanced productivity. Our expertise helps you optimize processes, identify areas for improvement, and drive business success.
Our experienced auditors conduct routine, directed, and for-cause audits of investigator sites. Through meticulous assessments, we identify areas for improvement and verify the adherence of site practices to GCP standards.
Our experienced team conducts rigorous audits of the pharmacovigilance processes of sponsor country business partner / vender organizations.
Our experienced auditors conduct thorough assessments of laboratory facilities to evaluate compliance with GLP regulations.
CDER and CBER have partnered with the European Medicines Agency (EMA) to establish 10 guiding principles aimed at assisting industry and product developers in utilizing
