Regulatory Affairs
Streamlining Strategy to Submission
At Exact Clinical Research, we understand that regulatory strategy is the foundation of every successful clinical program. As a FLEX CRO, we provide senior-level regulatory insight paired with agile, precise operational execution - helping small biotech and emerging pharma companies navigate complex requirements with confidence.
High-quality submissions accelerate development timelines—bringing new treatments to patients faster and maximizing the value of your research investment. Whether you’re preparing your first IND or managing complex global follow-on submissions, Exact ensures every regulatory document, interaction, and milestone is delivered with clarity, quality, and full inspection readiness.
A Trusted FLEX Partner for Regulatory Excellence
Emerging sponsors rely on Exact for experienced, cost-effective regulatory strategy and operations support. Our regulatory professionals engage early, collaborate closely with your team, and guide you through the regulatory lifecycle—from pre-IND planning through post-approval maintenance.
Regulatory Affairs Services
Our regulatory operations services are designed to streamline your submissions and communications with health authorities worldwide.
Learn More About Our FLEX CRO Approach
Comprehensive Services
Why Choose Exact Clinical?
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Our nimble contracting and trial startup processes allow us to set up your trial and activate sites in weeks, not months.
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Pay only for the expertise you need—whether targeted monitoring or regulatory support, or an end‑to‑end program management.
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Early‑stage innovators and mid‑sized sponsors trust us as their clinical services partner because we protect both runway and rigor.
In a sea of rigid, big‑box providers, Exact Clinical Research pioneered the flexible CRO model—delivering the depth of a full‑service organization with the agility your program deserves. We also have the ability to place single specialists for short-term engagements that larger CROs are unwilling to handle. Acting as an extension of your team, we scale support up or down in real time to keep budgets lean, timelines tight, and data exact.
Experience Matters
Connect with Exact Clinical Research today and discover how strategic, experienced partners can move your next study forward with certainty.