Intervein Research Labs Pvt. Ltd. has successfully completed a recent inspection by the U.S. Food and Drug Administration, marking a key milestone in its regulatory journey. The inspection focused on the company’s in-vitro bioequivalence capabilities, particularly In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT), which play a crucial role in evaluating topical and transdermal drug products.
The inspection concluded without any observations requiring further regulatory action, reflecting the strength of Intervein’s quality systems, data integrity framework, and scientific rigor. This achievement represents the company’s fifth successful USFDA inspection, spanning both Good Manufacturing Practices (GMP) and Bioavailability/Bioequivalence (BA/BE) domains.
With this milestone, Intervein positions itself among a select group of Contract Research Organizations (CROs) in Gujarat to have undergone USFDA inspections across both GMP and bioequivalence functions. The company reaffirmed its commitment to delivering reliable, inspection-ready solutions to global pharmaceutical partners, aligned with evolving regulatory expectations.
The development highlights the growing capability of India’s CRO ecosystem in meeting stringent international quality and compliance standards.
