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Pharos Labs

Piece by piece, across every regulatory discipline.

HTA & Market AccessAMNOG Modul 1–4 · EU JCA · NICE & HASAMNOG Dossiers · EU JCA Multi-PICO · G-BA Written ResponsesRegulatory AffairsCTD Module 2.4–2.7 · SmPC → FHIR ePI XMLClinical Overviews · EMA FHIR ePI XML · Briefing Books & LoQCMC & QualityCTD Module 3 · QOS 2.3 · Annual PQR & CAPAModule 3.2.S / 3.2.P · Quality Overall Summary · Deviations & CAPACompliance & QCPre-Submission Consistency · Source VerificationCross-CSR Number Checks · G-BA Corrigenda Audit · 100% Citation LineageClinical DevelopmentICH E3 CSRs · Trial Protocols · IB & DSURClinical Study Reports · Trial Protocols (ICH M11) · Investigator BrochuresLiterature & SLRsPRISMA Screening · PICO Extraction · RegistriesPubMed & MEDLINE Search · Dual-Stage Screening · PRISMA Extraction Tables

Regulatory & Clinical Writing

Sources: CSRs · Protocols · IB · SmPC

Draft clinical overviews, study reports, and EMA ePI XML directly from CSRs and protocols.

CTD Module 2.4–2.7 ICH E3 CSRs EMA FHIR ePI XML Briefing Books
  • Drafts directly inside your house Word templates with tables and figures intact.
  • Cross-checks endpoints, dosages, and sample sizes across 30+ clinical study reports.
  • Converts approved Word SmPCs into schema-validated EMA FHIR ePI XML in minutes.
Read the SmPC ePI XML case study →

HTA & Market Access

Sources: CSRs · PubMed SLRs · G-BA & HTACG Rules

Build multi-PICO EU JCA and German AMNOG dossiers stress-tested against authority guidelines.

AMNOG Modul 1–4 EU JCA Dossier PRISMA SLRs Written Responses
  • Populates mandatory G-BA and EU JCA templates with page-exact source citations.
  • Audits every claim against IQWiG methods and historical G-BA Beschlüsse.
  • Automates dual-stage PRISMA literature screening and PICO extraction.
See HTA-Bench results (ISPOR Vienna)

CMC & Quality Assurance

Sources: Batch CoAs · Stability Tables · GMP SOPs

Compile Module 3 and Quality Overall Summaries from batch records and stability data without transcription drift.

CTD Module 3 QOS (Module 2.3) Annual PQR / APR Deviation & CAPA
  • Reconciles 3.2.S and 3.2.P specification tables 1:1 against Module 2.3 QOS.
  • Aggregates multi-batch analytical and stability pull-points into Word tables.
  • Cross-checks post-approval variation packages against ICH Q8–Q12.
Explore specialist agents

CROs & Writing Consultancies

Sources: Multi-Sponsor Libraries · House Styles

Deliver more client dossiers per senior writer with strict per-project sponsor isolation.

Client-Isolated Workspaces Reusable Workflows Audit-Ready Handover
  • Strict project-level access controls keep sponsor documents completely segregated.
  • Adapts to each pharma sponsor’s custom Word templates and style conventions.
  • Every citation links directly to the highlighted passage in the source PDF.
Review enterprise security & isolation
“Regulaido changes the way I interact with technology and gives me the opportunity to focus on strategic assessments and at the same time extracts fast as well as accurate clinical trial information.”
Susanne Schneller
Susanne Schneller · Head of Dossier at SmartStep Consulting GmbH
Medical writers reviewing clinical dossier evidence

See Regulaido on your own documents.

Bring an SLR protocol, a house Word template, or a dossier section. In 30 minutes we will run it live and answer your questions on workflows, EU hosting, and rollout.

Book a demo Talk directly with Florian

“Tell me which dossier, literature review, or Word template is eating your team’s week. We’ll test it live together.”

Florian Woeste
Florian Woeste
Co-Founder & Managing Director · Pharos Labs
florian.woeste@pharos-labs.com