W. J. Green & Associates

W. J. Green & Associates is a professional consulting firm that provides regulatory affairs, clinical research, and quality assurance services to the life sciences industry. The firm specializes in assisting pharmaceutical, biotechnology, and medical device companies with complex regulatory submissions to the FDA and international bodies, including IND, NDA, BLA, and PMA filings. Their service portfolio includes clinical trial design and management, quality system development (ISO 13485/QSR), and comprehensive auditing for GXP compliance. By bridging the gap between product development and regulatory approval, the company helps clients navigate the path to commercialization. They are particularly recognized for their expertise in strategic regulatory planning and post-market compliance for a diverse client base ranging from startups to established global healthcare corporations.