The Clinical and Regulatory Engine Behind Your Innovation

Franklin Life Science is led by drug developers who have delivered regulatory and clinical success to countless biopharma companies.

We partner with our clients to guide innovative products through clinical development to regulatory approval, ensuring every milestone is achieved with precision and strategic insight.

By packaging regulatory affairs, clinical execution, and product strategy in fractional headcount, we seamlessly integrate with your organization.

Our Origin Story

Co-founded by strategic thought leaders Greg Dombal who led Halloran and Geoff Meyerson who leads Locust Walk, Franklin brings an entrepreneurial mindset that allows clients to leverage our deep knowledge and proven execution experience. We help you efficiently navigate complex regulatory and development hurdles with confidence.

  • Academic Heritage

Ben Franklin is the namesake of the main road through UNC Chapel Hill, alma mater of CEO Greg Dombal, and founder of the University of Pennsylvania, alma mater of Co-founder Geoff Meyerson.

  • Innovation Culture

His innovation, entrepreneurial mindset, and creativity permeate our culture and inspire our team to develop the next generation of therapeutic breakthroughs.

  • Cross-Disciplinary Excellence

Ben’s ability to draw from diverse disciplines enabled him to solve complex problems and create lasting impact, a philosophy we apply to drug development.

Our Differentiation

Integrated Approach to
Product Development

Our seamless integration of product strategy, tactical planning, and execution is deliberately engineered for regulatory and commercial success.

Capital & Time
Efficient Mindset

We focus on what’s best for your program with right-sized engagements and product roadmaps that rapidly and cost-efficiently deliver therapies to patients who need them.

We Are SelectivE
WITH WHOM WE WORK 

We partner exclusively with companies developing impactful products that address meaningful unmet medical needs. Not everyone will meet our rigorous standards—and that’s by design.

Our Services

From early strategy to regulatory approval, we deliver comprehensive support across every critical function of drug development.  Our experience leads to successful INDs; smart clinical strategies to rapidly create product value; Breakthrough, Fast Track and Orphan Designations that enable development ; and efficient clinical studies producing robust data to support approvable NDA / BLAs.

CLINICAL
PRODUCT STRATEGY

Indication Selection & Clinical Development Plans
Stage appropriate Target Product Profiles
Define clinical study concepts and Target Sets

CLINICAL
PRODUCT TACTICS

Create protocols, IB & other study documents
Clinical budget & cost planning
Due Diligence for transactions or filings

Clinical
execution

Clinical Study (CRO) oversight & management
Create DSUR, Annual Reports & routine filings
Update and maintain CT.gov, CTIS, etc

REGULATORY
PRODUCT STRATEGY

Analyze and assess regulatory landscape
Define product appropriate regulatory strategies
Structure approaches for expedited pathways

REGULATORY
PRODUCT TACTICS

Create IND/CTA/IDE/Special Designation Filings
Transaction due diligence
Conduct FDA & other Health Authority Meetings

regulatory
execution

US Agent/Ex-US Health Authority Correspondent
Manage & publish submissions in various systems
Document and maintain regulatory compliance

>$5B

R&D Dollars Overseen

>100

REgulatory meetings

>20

product approvals

50

countries with trials

>100

first in human trials

>200

regulatory designations

>75

INDs filed

>200

efficacy trials

Contact Us

Error: Contact form not found.