Regulatory & Submission
Phase-Appropriate Strategy, Agency
Engagement & Submission Excellence
Navigate the global clinical regulatory environment with confidence. REV Clinical partners with sponsors to design phase-appropriate strategies, prepare persuasive agency interactions, and collaborate to author regulatory submissions. From Pre-IND/Pre-consultation meetings, IND submission, EOP meetings for drugs, biologics, and 505(b)(2) products to Sub-Q and IDE submissions for devices, along with submissions for marketing approvals, we streamline regulatory decisions and approaches for global clinical trials.
Global Regulatory
Strategy &
Submissions
Expertise
REV brings deep, hands-on experience in engaging regulators in the United States, India, Australia, and other global markets. We craft phase-appropriate regulatory strategies anchored to your target label, risk profile, and evidence plan.
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From initial filing through approval and post-approval maintenance, we coordinate timelines, correspondence, and health authority queries to de-risk pathways and expedite decisions.
Clinical
Development
Capabilities
REV guides novel active substances and 505(b)(2)
programs from concept to commercialization.
We identify viable candidates and indications, run data-driven feasibility assessments, and map the optimal regulatory pathway. Our team designs and executes an efficient clinical development plan, leveraging prior knowledge to reduce time and cost.
We prepare and manage pre-IND and IND packages, as well as NDA or ANDA submissions, with ongoing lifecycle maintenance. In parallel, we address market access early, including strategies for coding, coverage, and payment, to optimize market value and mitigate launch risk.
Scientific &
Medical Writing
Turn complex data into compliant narratives. Our writers develop protocols informed by best practices to align with regulatory standards, creating manuscripts and patient materials that accelerate reviews, inform decisions, and build global credibility.
- Protocol
- Informed Consent
- Investigational Medicinal Product Dossier (IMPD)
- Investigator’s Brochure (IB)
- Clinical and Nonclinical Summaries
- IND package
- IDE package
- Clinical Study Reports
- Clinical Evaluation Reports
REV Clinical’s
Integrated Clinical
Trial Solutions
Discover our comprehensive capabilities and services that accelerate clinical study startups, enhance execution, and mitigate risks.
REV Clinical’s
Therapeutic
Expertise
Explore our areas of focused therapeutic experiences and expertise.
Let’s Move Your Study Forward
Interested in connecting with REV Clinical’s team of interdisciplinary experts to answer questions, take action on your RFP, and clearly define next steps?