
Boston Biodevelopment Founded in 2009, Boston Biodevelopment is a premium boutique regulatory strategy consulting firm of highly experienced regulatory professionals, including former heads of regulatory affairs, providing world-class hands-on regulatory leadership and management throughout the development and approval of new therapies. Our clients come to us when they need immediately effective regulatory professionals embedded on their teams to help meet their development goals and bring the promise of life science to patients. Our consultants have deep expertise in regulatory development through approval and life cycle management beyond. We bring decades of experience developing regulatory strategy, leading the planning, preparation, and defense of marketing applications and INDs, as well as meetings with health authorities and related submissions across geographic regions. Our regulatory strategists have all served as global regulatory leads and most of us are former heads of regulatory affairs. Our regulatory program managers all have experience leading NDAs/BLAs/MAAs. We are seasoned leaders, providing a credible regulatory voice with development teams, management, and regulators. Consulting Firm

Boston Biodevelopment

Founded in 2009, Boston Biodevelopment is a premium boutique regulatory strategy consulting firm of highly experienced regulatory professionals, including former heads of regulatory affairs, providing world-class hands-on regulatory leadership and management throughout the development and approval of new therapies. Our clients come to us when they need immediately effective regulatory professionals embedded on their teams to help meet their development goals and bring the promise of life science to patients. Our consultants have deep expertise in regulatory development through approval and life cycle management beyond. We bring decades of experience developing regulatory strategy, leading the planning, preparation, and defense of marketing applications and INDs, as well as meetings with health authorities and related submissions across geographic regions. Our regulatory strategists have all served as global regulatory leads and most of us are former heads of regulatory affairs. Our regulatory program managers all have experience leading NDAs/BLAs/MAAs. We are seasoned leaders, providing a credible regulatory voice with development teams, management, and regulators.

Consulting Firm