regulatory affairs
trusted
partner
to life sciences in the hub and beyond
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.
regulatory expertise
Boston Biodevelopment has deep expertise in regulatory affairs across a wide range of therapeutic areas and rare disease in all modalities in biopharma. Our consultants excel at guiding the regulatory development of biologics, small molecules, cell and gene therapies, and gene editing products through the entire product lifecycle.
our
services
Our highly-skilled and highly-experienced consultants provide the hands-on regulatory leadership and management you need to help guide your program from pre-IND through approval.
No arm's length consulting here. We are embedded on your team and committed to being indistinguishable from your permanent staff in our dedication to advancing your regulatory milestones and bringing your medicines one step closer to patients.
Meetings
GlobalRegulatoryStrategy
Breakthrough
Health Authority
IND
INTERACT
PIP
orphan
PRIME
Advisory
Committee
Fast
Track
ILAP
MAA
BLA
Regulatory
Intelligence
NDA
Label
DueDiligence
CTA
RMAT
IMPD
US Agent
FDA
Authorized Contact
our
team
Helena Correia
Founder &
Chief Executive Officer
Angela L. Nelson
EVP & Partner
Chief Strategy Officer
James T. Rawls
EVP & Partner
Chief Regulatory Officer
Anna Hertzberg
Director, RA
Senior Consultant
Liz Johnson
Director of
Operations
Kim Parthum
Vice President, RA
Principal Consultant
Bridget Walton
Vice President, RA
Principal Consultant
meet the whole team
617-249-4393
Boston Biodevelopment, LLC
6 Liberty Square #2483
Boston, MA 02109
medicines don't make themselves
you've already done the hard part