about
us
regulatory affairs partner
to small and mid-size life sciences companies
our mission
We leverage our talents and knowledge of regulatory affairs to help small and mid-size biopharma companies harness their innovation and agility to advance new and needed medicines through clinical development and onto the market as efficiently and quickly as possible.
Founded in 2009 by Helena Correia, Boston Biodevelopment is a boutique regulatory affairs consulting firm serving the needs of life sciences companies for hands-on and highly experienced regulatory leadership and management at critical junctures in product development.
Our purpose is to serve as a beacon of excellence for seasoned regulatory affairs expertise, attracting both clients and consultants looking for like-minded colleagues who have the skill, independence, and the confidence to be the voice of regulatory at the table, guiding product development throughout the regulatory pathway to approval.
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.
our
story
