Your product is ready. EU compliance rarely is.
We pair hands-on biotech and production-floor experience with rigorous regulatory research, so supplement brands enter Poland, Germany and the wider EU without the surprises that derail a launch.
Three pillars, one accountable team
Every engagement draws on the same core capability — we just apply it differently depending on where you are.
Compliance
Label reviews, health-claims mapping, and registration notification handled against the exact article numbers regulators check.
Supplements
Real GMP production-floor experience behind every recommendation — formulation, manufacturability and CMO matchmaking included.
Market access
Commercial and import/export knowledge built into every audit — so compliance work leads somewhere you can actually sell.
Fixed-fee projects, no ambiguity
Every service below is scoped before we start — you know exactly what you're getting and what it costs.
EU Market Entry Audit
Full compliance review — product classification, ingredient compliance, label elements, health claims and notification pathway, with a prioritised risk register.
Label Compliance Review
Pass/fail review against EU Reg. 1169/2011, Directive 2002/46/EC and national authorities country requirements, with corrective wording for every failure.
Health Claims Audit
Every intended claim mapped against EFSA Regulation 432/2012, with approved wording and claim ID for each.
Monthly Regulatory Retainer
Ongoing regulatory and compliance monitoring, proactive alerts on relevant changes, new SKU support and a dedicated regulatory contact.
CMO Production Brokerage
We source 3–5 comparable quotes from vetted, GMP-certified manufacturers and manage the technical back-and-forth.
Every finished-goods format, one point of contact
We match your product to vetted, GMP-certified manufacturers across the format you need — no single-CMO limitations, no format guesswork.
Functional Gummies
Chewable, taste-led format popular with wellness and children's brands; one of the most popular growing formats of supplements. 50+ formulations possible after first call. Vitamins, minerals, creatine — tell us what you need.
Functional Liquids
Drops, sprays, shots and syrups built for fast absorption and easy dosing — a strong fit for beauty, energy and immune-support products. Vitamins, herbals, adaptogens, mushrooms and much more.
Soft Capsules / Softgel
Oil-based actives such as omega-3, vitamin D and other popular ingredients sealed in a gelatin or plant-based shell, with strong bioavailability.
Hard Capsules / Hard Shells
Powder or granule fill in a two-piece shell — flexible for blends, probiotics and clean-label formulations.
Tablet and Effervescent Tablets
Cost-efficient with a long shelf life and easy branding; effervescent formats add fast-dissolve, higher-dose delivery.
Functional Powders
Sachets or tubs for protein, greens, collagen and electrolyte blends — a simple, low-cost format to launch with.
Other
Sprays, patches, gels, oral strips and other novel delivery formats, sourced case by case through our CMO network.
EU, GCC and other
We support supplement brands across Europe, the Gulf region and selected international markets, combining local regulatory knowledge with practical market-entry support.
Europe
- Poland (GIS)
- Germany (BVL)
- Czechia (SZPI)
- Austria (AGES)
- Netherlands (NVWA)
- Belgium (FASFC)
- Sweden (Livsmedelsverket)
- France (DGCCRF)
- Switzerland (FSVO)
- Spain (AESAN)
- Portugal (ASAE)
- Norway (Mattilsynet)
- United Kingdom (FSA)
- Italy (Ministero della Salute)
- Denmark (Fødevarestyrelsen)
- Finland (Ruokavirasto)
- Ireland (FSAI)
GCC
- Saudi Arabia (SFDA)
- Oman (MOH)
- UAE (MOHAP)
- Qatar (MOPH)
- Bahrain (NHRA)
- Kuwait (MOH)
Other
- USA (FDA)
- Canada (Health Canada)
- Mexico (COFEPRIS)
We've worked the floor, not just the paperwork
Most regulatory consultancies are law firms with no production knowledge, or solo practitioners without the bandwidth for international clients. We combine both.
Real production-floor experience
We've personally managed GMP supplement production runs — manufacturability answers come from experience, not theory.
International sales knowledge
Direct experience in EU supplement distribution and import/export shapes every market-entry recommendation.
German-language capability
DACH clients receive proposals and communication written natively in German — not translated after the fact.
Research-assisted, expert-reviewed
Regulatory research is accelerated by our own tools, but every output is reviewed and signed off before it reaches a client.
No commitment, no sales pitch
Just a direct conversation about your product and situation. We reply within 24 hours on business days.
Book a discovery call
30 minutes. We ask about your product, target markets, timeline and current compliance situation — then tell you exactly what it needs.
Email us to book a call