Biomedical Consulting International, Inc. (BCI) is a global regulatory center of excellence with office locations around the world offering a one stop shop for regulatory and dossier submission needs for drugs, biologics and medical devices. BCI consultants are experts in global regulatory strategy, product development, pharmacology/toxicology, chemistry, manufacturing and controls (CMC), clinical trial design, and patient safety. BCI offers Clinical Safety capabilities to support new and marketed products. All of our consultants are either experienced pharmaceutical/biotechnology professionals or former regulatory authority reviewers. BCI consultants have demonstrated successful product approvals. BCI has offices in the United States, India, Europe and Japan. Our 50+ consultants are experts in the development and registration of drugs, biologics including cell and gene therapy products, and medical devices. Their expertise includes: Global Regulatory Strategy Product Development (new drugs and generics; biologics and Biosimilars; medical devices) Strategies Nonclinical and Clinical Pharmacology and Pharmacokinetics; Toxicology Chemistry, Manufacturing, and Controls (CMC) Clinical Development including trial design and statistical analyses of data Pharmacovigilance and drug safety Medical and regulatory writing Due Diligence for in- and out-licensing of medical products With their decades of experience and knowledge of differing regulatory processes around the world, our consultants are able to provide regulatory and product development advice from both American and worldwide perspectives. Additionally, BCI's extensive network makes it possible for us to find the experts with the precise qualifications to meet your specific needs.