A Message from Our President & CEO
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| I would like to thank you for your business and long-standing support of Biologics Consulting Group (BCG). As you know from having interacted with our consultants, the BCG team is recognized for bringing a diverse clinical and scientific background to our understanding and interpretation of the FDA regulations of biologicals, drugs and devices. Moreover, BCG has established a strong track record of advising clients on the intricacies of the FDA and international regulations and requirements for entry of safe and effective products into the market place. Many of our consultants are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry who have a hands-on familiarity with FDA procedures and expectations. I am pleased to be leading a tremendously talented and knowledgeable organization, and want to assure you that the quality of service and advice that you have grown to expect from BCG will continue.
Today, we are experiencing a renaissance in the treatment of disease as a result of scientific discoveries ranging from genetic sequencing of the human genome to advances in our understanding of the human immune system. These scientific achievements have led to significant advances in clinical medicine such as the development of novel cellular therapeutics and new delivery systems that could significantly increase our life expectancy and the quality of life. Under my leadership, BCG’s primary focus will be to assist the industry in advancing public health throughout the world by facilitating the development and licensure of a new generation of therapeutics, vaccines and medical devices. BCG will continue to expand our scientific and regulatory knowledge and expertise into areas such as combination products, biosimilars, and personalized medicines. With strong partners such as you, together we will succeed in bringing innovative safe and effective products to the public. I look forward to our future collaborations. Sincerely, |
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