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Boston Biodevelopment regulatory affairs consultants

regulatory affairs 

trusted 

partner

to life sciences in the hub and beyond

biologics drugs medicine gene therapy

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 regulatory affairs consultants

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

Boston Biodevelopment regulatory affairs consultants

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

Interim Heads of Regulatory

Filing Leads and Support

Global Regulatory Strategists

Advisory
Board

Regulatory Project Managers

our
team

meet our featured consultants

Helena Correia

HelenaCorreia_-18_edited_edited.jpg

Founder &
President

Liz Johnson

Johnson, Liz_ Boston Bio Development 04134 1.jpg

Consulting
 Operations 

Boston Biodevelopment regulatory affairs consultants
On a Video Call

info@bostonbiodevelopment.com

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

learn how we can help you navigate the rest of the development journey

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