Built around your
product's full lifecycle.
Regulatory Affairs
End-to-end regulatory support — from strategy and submissions to lifecycle management — across EU, US, Canada, ANZ, GCC, Switzerland, South Africa, Latam, and ROW markets.
Pharmacovigilance & Materiovigilance
Turnkey safety systems for medicines and devices — QPPV, PV setup, signal management, RMPs, and inspection readiness.
All 16 services,
in one view.
Regulatory Strategy
Pathway identification, biowaiver and bioequivalence strategies tailored to your product and markets.
Learn moreGlobal Expansion
Leverage EU/US approvals for accelerated access to Canada, ANZ, GCC, Switzerland, South Africa, Latam, and ROW.
Learn moreRegulatory Intelligence
Continuous monitoring to identify risks and opportunities and inform your compliance posture.
Learn moreMarketing Authorizations
New submissions, variations, renewals, annual reports, and eCTD publishing — plus MA holding.
Learn moreAuthority Meetings
Effective engagement with authorities — agenda planning, briefing books, and documentation.
Learn moreTechnical Documentation
CMC, risk assessments, clinical and non-clinical overviews to current ICH guidance.
Learn moreDossier & eCTD
Module 1–5 authoring, baseline conversion, eCTD publishing and validation.
Learn moreTranslation & Labeling
PI and DMF translation, artwork preparation, mock-up review, and lifecycle management.
Learn moreQPPV & Local Rep
24/7 QPPV and Deputy QPPV cover, plus LSO and Contact Person services across regions.
Learn morePV System Setup
PSMF authoring, safety database setup, SDEAs, data migration, and ongoing stewardship.
Learn moreLiterature Screening
Systematic global literature monitoring for ADRs and signals — FDA, EMA, ICH-aligned.
Learn moreCase Processing (ICSR)
ICSR receipt, triage, processing, medical and quality review, and timely E2B submissions.
Learn moreAggregate Reports
PSUR, PBRER, PADER, and ACO authoring with medical and quality review through to submission.
Learn moreRisk Management Plans
EU-RMP and US-REMS authoring, updates, and mitigation strategy design.
Learn moreSignal Management
Scheduling, detection, validation, evaluation, and QPPV safety review aligned to GVP IX.
Learn moreQMS
SOP development, GAP analysis, and audit readiness across PV and regulatory operations.
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Flexible engagement —
built around your priorities.
Whether you need a one-off submission or an embedded long-term partner, we adapt to your model — not the other way around.
Project-Based
Best for product-specific submissions or a defined deliverable with a clear scope and timeline.
Retainer Model
Predictable monthly engagement with priority response and ongoing strategic support.
Dedicated Support
Embedded regulatory or PV resources working as a seamless extension of your team.
One-Time Remediation
Targeted help to close gaps before an inspection, audit, or critical filing deadline.
We'll help you map
the right service mix.
A 30-minute consultation, no commitment. We listen, ask the right questions, and tell you what's realistic — based on your product, stage, and target markets.
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Senior practitioner on the call — not a salesperson
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Honest assessment of timeline, scope, and risk
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No obligation — we'll happily refer if it's not a fit
Ready to start a
conversation?
Tell us what you're working on. We'll listen first, then propose the right service mix.