About Us

We are a team of dedicated professionals who are passionate about providing top-quality services to our valued customers. With years of experience in our respective fields, we strive to deliver excellence in every aspect of our work.

About Assuregxp

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 recognize that quality is not merely a regulatory requirement but a strategic asset that can propel businesses to new heights. Our primary objective is to empower our clients’ quality management programs, transforming them into a competitive advantage.

Rahul Mitra

Founder & CEO

Rahul began his industry career in GMP and then moved in the clinical research industry in 2004. In his previous roles and as Senior Auditor in one of the largest contract research organization, Rahul was responsible for conducting various GCP audits (Phase I to IV), Investigator Site Audits (ISA), Trial Master File, Clinical Trial Supply (CTS) depot, Data Management, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Phase I units including Bioavailability and Bioequivalence studies and vendor assessments.

Rahul moved into independent consulting in 2011. In his previous role and as GXP consultant, he has conducted over 350 GxP (GCP, GLP, GVP, GPP and GMP) audits across 35 countries and has actively participated in rolling out various quality processes & procedures. Have hosted regulatory inspections and customer audits. In the consulting role Rahul have had the opportunity to work with top global pharmaceutical companies and consulting firms. Have provided auditing and compliance related services to pharmaceutical country organization in pharmacovigilance, clinical development, medical and commercial, data integrity, computer system validation. Had been certified with Eudravigilance on electronic reporting of ICSRs.

In GMP area Rahul has been involved in internal review (IR) and Data integrity investigation for companies with AIP and consent Decree. Rahul has been involved in review of batch records, stability data, validation and qualification data and revie.

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