Advancing Drugs and Medical Device Technologies
from Discovery to Commercialization

Regulatory

Our extensive knowledge and experience can guide your novel drug or medical device through the complicated and complex FDA approval process.

Regulatory

Our extensive knowledge and experience can guide your novel drug or medical device through the complicated and complex FDA approval process.

Strategy

Our risk-based strategic roadmap can provide you with an  integrated and adaptive pathway to commercialization that mitigates time and cost.

Strategy

Our risk-based strategic roadmap can provide you with an integrated and adaptive pathway to commercialization that mitigates time and cost.

Clinical

Transforming a new drug or medical device entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate the clinical development process through all clinical phases.

Clinical

Transforming a new drug or medical device entity into a treatment opportunity is a complex, expensive, and time-sensitive process. We help you navigate the clinical development process through all clinical phases.

Project Management

Our dedicated team is ready to help you accelerate your product to commercialization. Our fully integrated and problem-solving approach provides a cost-effective on-demand solution to achieve your goals.

Project Management

Our dedicated team is ready to help you accelerate your product to commercialization. Our fully integrated and problem-solving approach provides a cost-effective on-demand solution to achieve your goals.

Commercial Support

Commercial support for early technology development is essential. We have a proven ecosystem of support services to advance your strategic objectives.

Commercial Support

Commercial support for early technology development is essential. We have a proven ecosystem of support services to advance your strategic objectives.

Market Entry Solutions

U.S. Market Entry

We provide a comprehensive suite of customized services to help international life science companies transition to the US market and to understand the US FDA regulations and business practices.

Risked-Based Assessments

Risked-Based Assessments

We can provide in-depth technical expertise for the assessment of likelihood of product development, regulatory, clinical, and commercial success and return on investment.

Investor Readiness

Investor Readiness

Raising funds? We have the experience and knowledge to help our clients be investor-ready to raise capital or meet strategic partners to accelerate research discoveries to commercial success.

Life Science Entrepreneurship

Life Science Entrepreneurship

Learn to efficiently convert a research project into a commercial product through our Entrepreneurship Bootcamp. Our faculty covers investor preparedness, regulatory strategy, IP protection, and other core pillars of commercial success.

Get a deeper understanding of what we do

Our Team’s Success Speaks for Itself

Indicators

%

Class 1 and 2 medical device approvals by the U.S. FDA.

%

U.S. FDA INDs submitted and accepted on time.

Experience with over 500 drugs and therapeutics.

Dilutive capital raised for our clients through our partnering and investor relation programs.

Successful U.S. FDA IND, NDA, BLA, 505(b)1 and 505(b)2 submissions.

Successful FDA CDRH Class 1 and 2 medical device submissions.

Special Designations granted.

Connected to over 700 clinical sites.

Partnered with over 15 academic incubators and accelerators.

Only CRO hosting an Annual Life Science Partnering event at J.P. Morgan Health Care Conference.

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