They entrusted us with their brand, From sourcing to compliance
Brands and retailers that wanted to launch or develop their own range of medical devices, without managing the manufacturing process themselves halfway around the world or navigating the regulatory maze. Here’s how we supported them.
Case study 1: OTC distributor · Belgium
Custom-branded nasal lavage syringes, from sourcing to compliance
A Belgian OTC distributor which represents in pharmacy a wide range of non-prescription products, for its own brand.
The need to leave :
The request concerned a box of 2 nasal lavage syringes of the customer's brand, For the Belgian market, the product part was clear; the regulatory part was much less so: who is the manufacturer, who is the European agent, who is the importer, what information must appear on the box, in which languages, and what documents must accompany each batch.
There were also some difficult exchanges with the factories and deadlines that were impossible to meet or even keep up with. Smart Agents took control of the whole process: a specification document kept in front of the factory, on-site quality controls during production and before shipment, a controlled schedule right up to delivery in Belgium, and a regulatory component from start to finish.
What we provided
A box of 2 graduated 10 mL syringes with flexible silicone tips, for nasal washing of infants from 4 months of age.
| Composition | Graduated syringe 10 mL (x2), flexible silicone tip (x2) |
| Materials | 56 % PP, 32 % silicone, 12 % rubber |
| Material guarantees | No BPA, no phthalate, reusable product |
| Usage | Nasal washing from 4 months of age |
| Packaging | Syringes in a hermetic sachet, box printed with a European eye |
| Packaging | 200 boxes / carton, carton size 57 x 35.5 x 28 cm |
| Shelf life | 3 years |
Fully customized packaging: brand identity, 4M+ pictogramming and no BPA, and all regulatory markings in three languages (FR / NL / DE).
The certifications
- EU Declaration of Conformity, MDR (EU) 2017/745, Class I medical device (Rule 13, Annex VIII)
- Economic operators' chain established and registered: manufacturer, European agent, Smart Agents as importer (SRN FR-IM-000017149), customer as distributor
- Regulatory identifiers: Basic UDI-DI from the manufacturer, GTIN13 code assigned by Smart Agents, batch number and expiry date
- Master text trilingual FR/NL/DE and standardized symbols EN ISO 15223-1
- Quality controls carried out by our teams on-site, during production and before shipment
- Certificate of Analysis (COA) and lot file submitted before goods are received in the warehouse
The implementation period
| Validation of the master text and the sets (BAT) | ~ 35 days |
| Manufacturing (after BAT validation) | 45 days |
| On-site quality controls | 1 j / control |
| Maritime shipping (Shanghai – Antwerp) | 45 to 60 days |
| Delivery to customer warehouse | Within 7 working days |
The result:
The first order, 10,000 boxes, was manufactured, checked and then delivered with its analysis certificate and batch file. A customer who did not know where to start with the regulatory issue or one from one end of the world has today a reference to its brand, compliant with the MDR and ready for the pharmacy. Other products from its range are now being developed with our teams.
Case study 2: Pharmaceutical group in France
More compact hydrophilic cottons and customized packaging
A group of French pharmacies focused on hygiene, health and beauty, offering quality/price products in pharmacies.
The need to leave
The initial request concerned a classic entry-level product: a bulk cotton bags, Following the model of the market’s cottons, Smart Agents has challenged this demand and proposed a more qualitative configuration: a column-based arrangement inside the bag, instead of an unorganized bulk, and more compact and denser cottons. The result of the compaction is a pile of 100 pieces measuring 19 cm (± 5 %), for a cleaner appearance at opening and a better display on the shelf.
What we provided
A bag containing 200 rectangles of hydrophilic cotton 100 % cotton, in the size 8 x 10 cm.
| Composition | 100 % cotton absorbent |
| Weight | 180 g/m² |
| Dimensions | 8 x 10 cm |
| Compactness | 19 cm (± 5 %) for a pile of 100 pieces |
| Packaging | 200-piece drawstring zip pouch, column storage |
| Packaging | 10 sachets / carton, carton of 41.5 x 40 x 21 cm |
Fully customized packaging: visual identity, zip bag with cord and all regulatory markings printed on the bag.
The certifications
- CE marking, Class I, self-certification by the manufacturer
- EU Declaration of Conformity, MDR (EU) 2017/745, Class I medical device (Rule 4, Annex VIII)
- Regulatory identifiers: Basic UDI-DI from the manufacturer, GTIN13 code assigned by Smart Agents, batch number and expiry date
- Master text in French and standardized symbols EN ISO 15223-1
- Quality controls carried out by our teams on-site, during production and before shipment
- Batch file transmitted before the goods are received in the warehouse
The implementation period
| Validation of the decor (BAT) | ~ 30 days |
| Manufacturing (after BAT validation) | 45 days |
| Maritime shipping | 45 to 60 days |
| Delivery to customer warehouse | Within 7 working days |
The result
The return is positive: the cotton does not easily shrink, a sign of better quality compared to the initially envisaged offer. Sales have been growing since the launch, and the relationship has established itself over time with approximately 5 reorder orders per year.
Case study 3: Distributor in France
A % customized 1 L solution for NaCl 0.9 irrigation
A French distributor who launched his own brand of baby care products, sold in pharmacies.
The need to leave
This client identified us after conducting an online search and consulting our website. His first request concerned irrigation solution bottles in 1 L and 500 mL formats. Being used to distribution, he was launching his own brand for the first time, with all that that entails in terms of production and regulatory requirements: these are the two aspects that Smart Agents he accompanied her.
The first order included both formats. In terms of sales, the 1 L format better met the needs of its customers; subsequent orders therefore focused on replenishing the 1 L product in full container sizes.
What we provided
A 1000 mL BFS (Blow-Fill-Seal) bottle of 0.9% sodium chloride solution %.
| Composition | NaCl 0.9 %, 99.1 purified % water |
| Format | BFS 1000 mL bottle |
| Cap | Graduated dosing syringe (4, 8, 15, 18 mL), with safety ring |
| Label | 135 x 95 mm, PE material, dedicated Pantone colors |
| Packaging | 8 bottles / carton, carton size 35.5 x 18 x 27.8 cm |
Fully customized label: visual identity, illustrated mascot and step-by-step instructions for using the cork stopper printed on it.
The certifications
- EU Declaration of Conformity, MDR (EU) 2017/745, medical device class Is
- EUDAMED powered by Smart Agents: new to the in-house brand; the customer didn’t have to manage it
- Economic operators' chain established and registered: manufacturer, European agent, Smart Agents as importer (SRN FR-IM-000017149), customer as distributor
- Regulatory identifiers: Basic UDI-DI from the manufacturer, GTIN13 code assigned by Smart Agents, batch number and expiry date
- Quality controls carried out by our teams on-site, during production and before shipment
- Certificate of Analysis (COA), Certificate of Irradiation (COI) and batch file submitted before acceptance
The implementation period
| Validation of the decor (BAT) | ~ 30 days |
| Manufacturing (after BAT validation) | 45 days |
| Maritime shipping | 45 to 60 days |
| Delivery to customer warehouse | Within 7 working days |
The result
The return is positive; the customer is satisfied with the finished product. The relationship has been established over time, with 2 to 3 orders for re-stocking per year.
They trust us
Our partners
Laboratories, pharmaceutical groups, and distributors who trust us.
Today we are supporting several major players in the pharmaceutical sector, such as’Evolupharm, Pharma Best or else Juvasanté, in the development and manufacturing of their private label physiological serums.
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Do you want to launch your brand?
From sourcing to quality controls, from manufacturing to MDR compliance, we take your project from start to finish.