Schiff & Company, founded in 1982, is an international Regulatory Affairs, Compliance and Clinical Research Organization. Its fields of expertise include drugs, biologics, devices, foods and cosmetics. The company represents both domestic and international organizations to the FDA and to foreign regulatory bodies. It conducts and monitors clinical studies and writes all appropriate regulatory filings, i.e., NDA’s, BLA’s, PMA’s and 510(k)s. The staff plans regulatory strategy, prepares clinical development plans, performs GMP, GCP and GLP audits, writes SOPs and conducts due diligence. The company has performed clinical trial activities for many of the top 100 drug and device companies.
mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations. Read More
SHL Healthcare’s original parent company, SHL Group, was first established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf. The company has since become a world-leading manufacturer of advanced drug delivery devices such as auto injectors, pen injectors and inhaler systems for... Read More
Paladin Medical®, Inc. provides efficient and effective medical device regulatory and development consulting to the medical device industry. We champion your new product through all phases of product development, testing and submissions to get your product to the market. Whether your project...