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Tailored, Data-Focused Scientific Strategy

Scientific + Medical Affairs Consulting

100+ Clients

100+ Trials

45+ Launches

40+ Regulatory Submissions

The team behind approved drugs and cleared diagnostics, now behind your program.

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About Us

From preclinical through launch, we design and execute clinical development, regulatory, microbiology, biometrics, and medical affairs strategy across the infectious disease, immunology, critical care, rare disease, and diagnostics markets.

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Trusted by 100+ clients, 100+ clinical trials, 45+ product launches, and 40+ regulatory submissions.

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Deep, hands-on experience across the life sciences, from Phase 1 through Phase 3 programs in infectious disease, immunology, critical care, and rare disease therapeutics.

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Schedule a conversation to discuss how we can support you and your program needs.

Product Strategy

We provide scientific expertise that can be leveraged to support drug development, regulatory strategy, and differentiation of products. Our goal is to be the single source for clinical microbiology, medical affairs, and commercialization strategy. We work to ensure a seamless transition from clinical development to commercialization to support brand success.

Launch Preparation

We support commercial readiness by implementing differentiation strategies, data generation and dissemination, and process management to optimize product attributes and maximize product launch success. We specialize in commercial readiness, medical affairs execution, clinical microbiology and medical affairs operations.

Clients

We are a therapeutically experienced consulting group that acts as a strategic partner, offering specialized expertise and guidance throughout the drug development process. We focus on scientific, medical affairs, and commercial strategy. By working closely with our clients, we help in maximizing the commercial success of pharmaceutical and medical device products.

Testimonials

“You have a drug in late stage development and only a hint of a medical affairs strategy, what do you do? You panic, pray or call SMAC. When called upon they provided functional expertise, staffing support and a networking strategy that helped relationship building. We’ve worked with

SMAC for almost 4 years and our growing Medical Affairs team and strategic approach have benefited tremendously from this relationship.”

CMO, Pharmaceutical Company

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