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.
With more than 85 years as a parenterals specialist, Baxter’s BioPharma Solutions business offers contract manufacturing form/fill/finish services and solutions for injectables designed to meet complex and traditional sterile manufacturing challenges.
We are a leading contract manufacturer of... Read More
Aphena Pharma Solutions is a top-ranked service provider in the pharmaceutical, medical device and biologic industries. Aphena provides clients with a full range of pharmaceutical packaging and manufacturing services to advance their products to market --- complete, on time, on budget. With our... Read More
Triclinic Labs provides contract pharmaceutical, medical device, and fine chemical solid-state development and materials analysis services. We offer complete organic and inorganic characterization, drug counterfeit and contaminant analysis, intellectual property support, and screening and... Read More