Regulatory Affairs.FDA · EMA · PMDA.

We prepare IND, NDA, BLA, MAA, and device submission packages for the United States, Europe, and Japan — from first-in-human through approval and post-market.

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Scientific Publications.Manuscript to Journal.

We write and place peer-reviewed manuscripts, develop publication strategies, and produce scientific content for CROs, pharma, and academic institutions — CONSORT, PRISMA, and STROBE compliant.

Scientific Publications

Independent Science.No Exceptions.

Our Systematic Reviews division is a free public service — no fees, no commercial interests, no compromise. Join our collaborative authorship program today.

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Evidence-Based

Every deliverable grounded in the best available evidence and highest methodological standards.

Scientifically Independent

Commercial interests never shape our science. Independence is our non-negotiable standard.

USA · Europe · Japan

Regulatory expertise for FDA, EMA, and PMDA across the full product lifecycle.

About Us

Scientific Rigor. Strategic Clarity. Unwavering Integrity.

Systematic Reviews, LLC is a full-service medical communications and regulatory affairs consultancy built at the intersection of science, medicine, and strategy. Work is performed by medical doctors, regulatory scientists, and professional medical writers engaged on a per-project basis and matched to therapeutic area and scope. We operate across five specialized divisions — each designed to advance science, support regulatory success, and communicate medical knowledge with the accuracy it deserves.

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Our Divisions

Five specialized divisions. One unified commitment to scientific excellence.

Medical Communications

Feature articles, medical news, and product communications — distilling cutting-edge science for clinicians, patients, and industry with accuracy and depth.

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Regulatory Affairs

IND, NDA, BLA, and device submissions for the FDA, EMA, and PMDA — strategic regulatory support across the full product lifecycle in the USA, Europe, and Japan.

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Scientific Publications

Manuscript development, publication strategy, CRO scientific content, and expert editing — getting the right science to the right journals and the right audiences.

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Continuing Medical Education

ACCME-compliant CME programs that close clinical practice gaps, advance medical knowledge, and meet the highest standards of educational independence.

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Free Public Service

Systematic Reviews

Rigorous, PRISMA-compliant systematic reviews conducted and published at no charge — the scientific backbone of everything we do. Authorship program now open.

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Work With Us

Pharmaceutical companies, biotechs, CROs, academic institutions, and individual researchers — we welcome all inquiries.

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Our Commitment to Independent Science

Our Systematic Reviews division is offered entirely free of charge as a public and scientific community service. No commercial interests. No participation fees. No exceptions. We keep this division completely independent because the best available evidence should be freely accessible to all — and because our credibility in every other division depends on demonstrating, not just claiming, that scientific integrity comes first.

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Ready to advance your science?

Whether you need regulatory submission support, medical communications, scientific publications, CME development, or wish to join our free systematic review authorship program — we are ready to work with you.

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