Dhinal Shah Associates

Dhinal Shah Associates is a specialized regulatory and quality compliance consultancy firm serving the pharmaceutical, biopharmaceutical, and medical device industries. Based in Ahmedabad, India, the firm provides comprehensive services including regulatory strategy, dossier preparation (CTD/eCTD), and quality management system implementation. They assist global clients in navigating complex regulatory landscapes for submissions to major agencies such as the US FDA, EMA, and MHRA. The company's expertise extends to GMP auditing, pharmacovigilance, and clinical trial regulatory requirements. By offering technical support for DMF, ANDA, and ASMF filings, they help manufacturers achieve international compliance standards. The firm acts as a strategic partner for healthcare companies seeking to enter or maintain presence in highly regulated global markets.