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About Biomedical Consulting International

Biomedical Consulting International, Inc. (BCI) is a global regulatory center of excellence with office locations around the world offering a one stop shop for all of your regulatory and dossier submission needs.

BCI consultants are experts in global regulatory strategy, product development, pharmacology/toxicology, Chemistry, Manufacturing and Controls (CMC) clinical trial design and patient safety. From this expertise, our consultants are able to provide regulatory and product development advice from both a US and international perspective. BCI consultants have considerable experience with all types of regulated pharmaceutical and biotechnology products including drug, biologics, medical devices and combination products. BCI also offers Clinical Safety capabilities to support clinical product development as well as approved products.

All of our consultants are either experienced pharmaceutical/biotechnology professionals or former regulatory authority management/reviewers. BCI consultants have demonstrated that they are able to focus their knowledge and experience to develop high quality license / marketing applications that meet the expectations of regulatory authorities as evidenced by the number of successful product approvals that they have supported.

BCI is a leading global consulting firm providing development and post-approval services whose clients include pharmaceutical, biotechnology and medical device organizations.

BCI currently maintains offices in the United States, United Kingdom, Japan and India with locations planned for Latin America, Australia and Canada.


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