About AlaQPharma
Romania-based partner for EU market entry—regulatory handling, market access execution, and compliant launch across channels.
What we are
AlaQPharma is built to bridge manufacturing markets outside the EU with regulated market access inside the EU. We focus on two categories where execution quality matters: medical devices and food supplements. Our approach is documentation-first, authority-aware, and commercial-ready—so products can launch in Romania compliantly and scale into other EU markets through a structured expansion plan.
AT A GLANCE
- Base: Romania (EU)
- Focus: Medical Devices (MDR/IVDR) + Food Supplements
- Execution: Authority workflows, dossiers, compliant launch
- Channels: Pharmacies, e-commerce/marketplaces, tenders (SEAP)
- Approach: Compliance-led, evidence-driven, scalable
What we do
Regulatory execution and market access for medical devices and food supplements—Romania-first, EU-ready.
MEDICAL DEVICES
EU MDR/IVDR Readiness
- Regulatory screening and pathway mapping
- Importer/distributor setup support and documentation discipline
- EUDAMED actor workflow support (SRN) + launch execution
FOOD SUPPLEMENTS
EU + Romania Compliance
- Formula and claims screening
- Labeling readiness (EU + Romanian)
- Romania notification dossier support (MoH / CRSP / IBA routes as applicable)
ROMANIA MARKET ACCESS
Romania Market Access
- Pharmacy onboarding support (chains + independents)
- Compliant e-commerce and marketplace readiness
- Tender readiness (SEAP): documentation packs and bid discipline
Why Romania-based helps your project
A practical EU entry base combines local authority handling with real launch execution.
Local regulatory handling
- Authority-facing workflows for medical devices and supplements
- Romanian language and dossier readiness
- Controlled documentation packs (audit-ready structure)
Launch execution & stakeholder access
- Channel execution: pharmacies, e-commerce, and procurement
- Materials packs aligned to compliance boundaries
- Field execution mindset: timelines, owners, deliverables
Structured EU scaling
- Medical devices: MDR/IVDR compliance and “information supplied” localisation
- Supplements: market-by-market readiness (composition/claims practice can vary)
- Mutual recognition where relevant, applied carefully with clear caveats
How we work
Screening
confirm route and risks
Readiness
label + documentation pack
Romania entry
authority workflow execution
Launch
compliant listings + channel rollout
Scale
structured expansion plan across EU markets
Compliance-first marketing & education
We support demand creation through compliance-led execution: claim-safe copy, pharmacy materials, and evidence-based education assets. For medical devices and supplements, we prioritise consistent messaging aligned to verified documentation—reducing risk while enabling commercial rollout across Romania’s key channels.
- Pharmacy activation: training packs and compliant POS
- E-commerce execution: claim-safe product pages + SEO structure
- Scientific materials: evidence summaries and Q&A for stakeholder education
How we protect your project
- We work documentation-first and keep evidence aligned across channels.
- We avoid overclaims and keep labels/marketing consistent with verified documentation.
- We treat Romania entry as a launch—not only as paperwork.