European pharma standards, now on U.S. shelves, FDA registered, manufacturing for U.S. nutra brands.

FDA registered, manufacturing for U.S. nutra brands.

EU + U.S. · TÜV Thüringen audited · FDA registeredEU + U.S. · TÜV audited · FDA

Supplement manufacturing that survives an audit.

One European pharma-grade facility for both markets. Every raw material re-tested on arrival, every released batch signed off by two labs, ours and an independent one. The CoA ships with your order.

2 labs
sign off every batch
100%
raw materials re-tested
3 markets
independently audited
Senad Bećirović, co-founder and CEO, in a PharmScale lab coat at the production line
"My signature is on every batch that leaves this factory."Senad Bećirović · Co-founder & CEO

For consumers

Bought a supplement or cream made in our facility?

Enter the batch number from your packaging to see where it was made, which labs tested it, and the results of every panel it passed.

What we make

Your formulation, run to pharma discipline.

From first sample to shelf-ready product: formulation, sourcing, production, testing and packaging under one roof in Srebrenik, shipped to the EU and the U.S. from the same certified line.

No. 01

Tablets

Direct compression and granulation lines, coated and uncoated formats.

No. 02

Capsules

Hard-shell capsules with verified fill weights on every production run.

No. 03

Powders & sachets

Blended, tested for homogeneity, filled to declared dose.

No. 04

Creams & topicals

Cosmetic GMP (ISO 22716) production with full stability documentation.

328 in-stock ingredients · popular actives:
  • Vitamin D3 · 5000 IU
  • Magnesium bisglycinate · 400 mg
  • Omega-3 EPA/DHA · 1500 mg
  • Zinc citrate · 25 mg
  • Ashwagandha KSM-66 · 600 mg
See the full catalogue →
Pipetting samples in the quality-control laboratory
independent lab · every released batch

Our QC discipline

Two labs sign off on every batch.

Most CMOs run one internal test and call it "lab tested." That's marking your own homework. We don't.

  1. Internal lab. Raw materials and in-process samples verified before production starts, identity confirmed, actives quantified to label, adulterants screened.

  2. Independent 3rd-party lab. Full panel on every released batch: microbiology, heavy metals, raw-material purity.

The independent CoA ships with every order. Fail any test, the batch doesn't ship.

How to read a CoA →

Quality & testing

Every batch goes through the same rigorous lab.

Not paperwork compliance. Every batch tested in our QC lab, plus an independent third party where the target market requires it.

QC dissolution lab
12+
In-house QC tests per batchIdentity · purity · potency · disintegration · uniformity
Stricter than EU heavy-metal limitsPb, Cd, Hg, As, every batch · why →
24 mo
Stability testedReal-time and accelerated, ICH Q1A compliant
3
Independent labs in our networkEU and U.S. accredited, used per target market
100%
CoA on every shipmentPer-batch assay results, share with retailers

Why this matters

The supplier CoA is testing the supplier's batch. Not yours.

Most CMOs accept the supplier's Certificate of Analysis at face value. We don't. Every raw material that enters our facility is re-tested in our own lab against the supplier's claim before it ever touches a production line, identity confirmed, actives quantified to label, adulterants screened. If the assay doesn't match, the batch goes back.

The supplier finds out fast, our line stays clean, and your brand never carries the recall. That extra step is what "pharma-grade" actually means in practice, and it's the test most brands skip.

Skin in the game

Our own brands ship from this factory. Yours can too.

We started in Europe, where conditions are stricter, and kept the same pharma standards when we expanded to the U.S. shelf. Our own brands, including PureNADH, co-founder Esef Ćosić's brand for the U.S. market, ship to EU pharmacies and U.S. e-commerce from this line, under the same two-lab QC, every month. When your batch runs, it runs on equipment our own revenue depends on.

"I'm a PharmScale client first. I have to answer 'can this really ship in 30 days at pharma quality' for my own brand every batch. The answer has to be yes, otherwise I don't ship, to anyone."

Esef Ćosić · Co-founder & Brand Operator

Project basics

What a PharmScale project usually looks like.

5,000
Minimum order, unitsSmaller pilots possible by arrangement
Free
Brief review & tailored quoteNo obligation, no signup, no NDA needed
Same-day
First reply, co-founder-ledDirect from Senad
100%
You own the formulationYour IP, your registration, your brand

Pricing depends on form, ingredients, packaging and markets. Configure yours in 3 minutes, Build my product →

The Single-Roof Method

Why we ship in 30 days when six-vendor CMOs take six months.

Every function, formulation, regulatory, design, production, QC, packaging, sits in one building in Srebrenik. No vendor relays. No "waiting on the printer." 30 days is the side effect.

No. 01

One facility, one contract

Pharmacist, designer and regulatory team under one roof. Decisions in hours, not email threads in weeks. Pre-validated formulations skip the development month.

No. 02

27 EU markets, the UK and the U.S., one dossier

Our in-house regulatory team keeps active dossiers in every market. File once. We adapt per country. No separate consultants. No "can't sell there yet" surprises.

No. 03

Stuttgart standards, Srebrenik invoice

Same TÜV/DAkkS audit as a German plant, same accredited body. Srebrenik labour and overhead run 50–70% below DACH and the UK. Same dossier, smaller invoice.

30
days from order to market
27
EU markets, plus the UK and the U.S.

PharmScale vs. typical CMO

One company instead of six.

Here's what changes, side by side.

CriterionPharmScaleTypical CMO
QC sign-offInternal + independent 3rd-party lab, every released batchInternal lab only, "lab tested" claim
Audit bodyTÜV Thüringen under DAkkS accreditation, on-site every year"GMP" claimed, third-party audit unclear
Per-batch CoAIndependent CoA, share-readyOn request, sometimes paid extra
Time to market30 days4–6 months
Minimum order5,000 units15,000–25,000 units

We're not the cheapest CMO, and we don't pretend to be. The brands that work with us have run the math: one recall, one rejected shipment, one regulator complaint costs more than five years of "value" formulation savings. Numbers above reflect what we hear from founders who shopped 5+ CMOs before signing with us.

Common questions

Things founders ask before they sign.

What's the smallest order you'll take?
5,000 units per SKU. Pilot batches are sometimes possible for repeat customers or high-margin creams, ask. Below 5,000, per-unit cost breaks the retail math, so most founders start at 5,000 and reorder. Read the full breakdown →
Who owns the formulation IP?
You do. Whether you bring your own recipe or we develop one for you under contract, the formulation, the brand, and the product registration are 100% yours. We don't sell or share your formula with anyone, not even other PharmScale clients in adjacent categories.
How does shipping and customs work for U.S. clients?
For U.S. clients we ship from our FDA-registered facility (Reg. No. 14287957814) on EXW or DAP terms. We handle FDA prior notice, the FSMA documentation and the bilingual labeling. Most U.S. brands work with a freight forwarder we recommend, customs clearance to a U.S. warehouse takes 5–7 business days from EU departure.
What if my first batch fails QC?
Our QC happens before any product leaves the facility. If a batch fails internal release testing it never ships, we re-manufacture at our cost. If a third-party lab finds a deviation post-shipment, we cover replacement and analytical re-testing. Every batch comes with a Certificate of Analysis you can share with your retailers.
Can I visit the facility?
Yes, please do. Sarajevo airport is 90 minutes from us by car, we'll arrange the pickup. Most clients visit during the formulation/pilot phase. You'll see the production floor, meet the team, and walk through the QC lab. No NDA needed for a tour.
How long does product registration actually take per market?
EU food supplements: 4–8 weeks per market once filed (some are notification-only, immediate). EU cosmetics: ~2 weeks via CPNP after the safety report. U.S. dietary supplements: 30 days for FDA prior notice, then live once your facility, NDIN (if needed) and labels are compliant. Send us your markets, we'll map the timeline.
How does pricing work?
Every project is priced individually because the inputs vary widely, form (capsule vs cream), ingredient cost, packaging complexity and the number of target markets all move the number. The first batch carries the formulation and registration work; reorders are significantly cheaper since that's done once. The fastest way to a real number is to configure your product, we reply with a written quote the same business day.
Where is the factory located?
Srebrenik, Bosnia and Herzegovina (Ćehaje bb, 75350). EU-aligned: ISO 22000:2018 and ISO 22716 GMP, TÜV Thüringen under DAkkS, plus FDA registration (No. 14287957814) for the U.S. Short EU lead times. Visits welcome, just ask.
I bought a product made here, how do I verify it?
Use the batch trace above or visit Where your supplement is made. Every batch we release has a Certificate of Analysis from an independent lab, email info@pharmscale.com with your brand and batch number (printed near the expiry date) and we'll send you the CoA for your exact batch.
Is PharmScale FDA approved?
Honest answer: the FDA doesn't "approve" dietary supplements or their manufacturers, anyone claiming to be "FDA approved" is misleading you. What actually exists: our facility is FDA registered (Reg. No. 14287957814) and follows 21 CFR Part 111, the FDA's manufacturing rulebook for supplements, verified through independent TÜV audits on top.

Ready to run your product to a standard you can defend?

Send us your formulation, or just the idea. We'll come back with a sourcing plan, testing panel and quote within five working days.