Pharmaceutical & Biotech

The pharmaceutical and biotech industries operate under some of the most stringent global regulations to ensure product safety, efficacy, and quality. At VSS Regulatory Services, we provide end-to-end compliance solutions, helping businesses navigate complex regulatory landscapes for drug substances, biologics, medical products, and active pharmaceutical ingredients (APIs).

Our expertise includes toxicology assessments, GLP audits, regulatory dossier preparation, and product safety evaluations to ensure compliance with FDA, EMA, ICH, and global pharmaceutical regulations. We assist with REACH compliance for excipients, chemical inventory management, import/export regulations, and notifications for pharmaceutical intermediates. Additionally, we coordinate toxicology studies with CROs, ensuring reliable data for risk assessments and regulatory submissions.

With VSS as your regulatory partner, you can focus on drug development, innovation, and patient safety, while we take care of the compliance complexities—ensuring seamless market entry and continued regulatory adherence.