Food Supplements (EU + Romania)
EU-aligned formulation and labeling readiness, Romania notification dossier support (MoH / CRSP / IBA routes as applicable), and compliant market launch via pharmacies and e-commerce.
Food Supplements – our capabilties
EU COMPLIANCE
Formula & compliance screening
- Classification: supplement vs borderline positioning
- Composition: ingredient forms, limits, prohibited/restricted substances check
- Claims risk: identify gaps before labels/content are produced
LABEL & CLAIMS
Labeling & claims readiness (EU + RO)
- EU label structure: mandatory elements, nutrition table where applicable
- Romanian language: localized label + consumer materials
- Claims discipline: compliant health claim approach and wording consistency
ROMANIA ENTRY
Notification dossier + Romania launch
- Dossier pack: aligned to MoH / CRSP / IBA pathways (as applicable)
- Submission support: correct forms + supporting documents
- Launch execution: pharmacy and e-commerce rollout, compliant listings
How it works
01 → 02 → 03 → 04 → 05
STEP 01
Regulatory screening
- Confirm product type and borderline positioning
- Review intended claims and compliance gaps
- Define the required documentation scope and timeline
Output: Screening memo + risk/gap checklist
STEP 02
Documentation & labelling readiness
- Align label content to EU mandatory requirements
- Build Romanian language label + consumer-facing texts
- Create a claims-safe copy framework for web/pharmacy materials
Output: Label/pack copy + claims-safe messaging set
STEP 03
Romania authorisations & notifications
Medical devices
- Prepare dossier according to the applicable route (MoH / CRSP / IBA, as relevant)
- Ensure composition and documentation meet expectations
- Support submission package completeness and traceability
Output: Romania notification dossier pack
STEP 04
Commercial launch in Romania
- Pharmacy onboarding support (chains + independents)
- Marketplace readiness: compliant listings, traceability language, returns logic
- Campaign setup aligned to compliance (no disease claims; disciplined wording)
Output: Launch plan + channel-ready content pack
STEP 05
Scale into other EU markets
- Expansion assessed market-by-market (composition limits, botanicals acceptance, labeling, claims practice)
- Where mutual recognition is relevant (typically non-/partly-harmonised areas), we structure a defensible approach with clear caveats and documentation of rationale.
Output: EU expansion roadmap (requirements + sequencing)
Marketing and launch delivery (compliance-led)
Pharmacy channel activation
- Onboarding support: listings, trade terms alignment, launch calendar
- Pharmacist education: product logic, compliant key messages
- POS materials: shelf talkers, leaflets, training decks
- Sell-out focus: promo mechanics aligned to channel constraints
E-commerce & marketplaces
- Claim-safe product pages: structured benefits language and disclaimers
- SEO foundation: category structure + intent-based content blocks
- Marketplace compliance: correct titles, attributes, returns/traceability language
- Performance marketing: disciplined creatives and landing pages
Scientific & medical education support
- Evidence pack: ingredient rationale + references summary (non-promotional tone)
- HCP education materials: scientific slides and Q&A documents
- KOL network support: compliant collaboration frameworks
- Congress / webinar support: booths, symposia, speaker decks (where applicable)
What we need from you
Minimum to start
- Formula (qualitative + quantitative) incl. excipients
- Draft label + intended claims
- Certificates available (GMP/HACCP/ISO)
- COA / test reports (if available)
Best-case package
- Full technical/spec sheet
- Stability rationale where applicable
- Supplier documentation + allergen statements
- Artwork files + translations
Ready to validate your formula and launch plan?
FAQ
Answer: We can’t guarantee; we can reduce risk and ensure completeness.
Answer: yes, as applicable
Answer: depends on dossier completeness and pathway; Usually 4 to 5 weeks if the dossier is complete.
Answer: yes; market-by-market assessment.
